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Role: Project Quality Manager\n\nLocation: Remote working with travel to Dublin and Germany\n\nStart Date: ASAP\n\nDuration: December 2028\n\nPay Rate: DOE\n\nOUTSIDE IR35\n\nJob Profile - Project Quality Manager\n\nPosition in Organization\n\nReports to the Project Lead\n\nLiaises directly with Customers and Customers' Representatives.\n\nLiaises with Suppliers on Quality matters\n\nLiaises at all levels internally to ensure Quality Requirements are achieved.\n\nLimits of Authority\n\nRepresents our client on quality matters at meetings with Customers / Customers' representatives.\n\nRepresents our client on quality matters with Suppliers.\n\nAuthority to produce Quality Documentation on behalf of the business.\n\nKey Responsibilities\n\nInterface with Customer to ensure all Quality Requirements are understood and added to controlling documentation as required.\nManage contract deliverables liaising with Engineering, Supply Chain Management, Manufacturing and Projects as necessary.\nWork with Engineering to ensure Quality Requirements are documented and updated to ensure Design intent is achieved and validated.\nProduce and manage Project Quality Plans ensuring all inspections and tests are carried out during Engineering, Procurement, Manufacture and Assembly stages.\nEnsure that all Siemens Energy and Customer Witness Hold Points and Quality Record requirements are added to relevant Inspection and Test Plans.\nRequest Suppliers to produce Inspection and Test Plans for the control of Quality Inspections, Hold Points and Records for supplied goods.\nCarry out Quality Reviews at Suppliers & ensure Quality Documentation submitted by the Supplier is complete and in compliance with contract.\nAttend as Siemens Energy Quality Representative at internal meetings and external meetings with Customers.\nManage the attendance of Customers' Representatives at identified stages of manufacture ensuring signoff of Witness Hold Points are documented.\nControl ATEX requirements during equipment installation including the production of necessary documentation to demonstrate compliance.\nManage PED requirements including pressure equipment categorization and conformity assessment liaising with approval authorities where necessary to ensure compliance.\nManage NCRs including the validation of corrections and ensuring RCAs and Corrective Actions are completed and documented in preparation for Lessons Learned.\nSupport Customer audits, inspections and regulatory visits.\nProvide Quality Status Reports to Project Management.\nReview work content to ensure any Special Process ie Welding, NDT, Painting, Lifting requirements are pre-approved, activities and certifications are validated and relevant records produced.\nRevision Service ITPs to reflect changes emerging during project.\nManage the compilation of a Manufacturing Record Book (MRB) for submission to the Customer as a permanent record of project quality.\n\nSkills & Competencies\n\nStrong understanding of ATEX, PED, and ISO 9001. Ability to read and interpret engineering drawings and specifications. Strong leadership, communication, and stakeholder management skills.\n\nQualifications & Experience\n\nEssential: Significant experience managing of Major New Build Projects in Power Generation or similar Industries. Practical experience of ATEX and PED.\n\nDesirable: HND / Degree in Engineering; Lead Auditor qualification; formal ATEX / PED training; experience interacting with Approved Bodies.\n\nRullion celebrates and supports diversity and is committed to ensuring equal opportunities for both employees and applicants

Computer System Validation & GxP Compliance Consultant/Senior Consultant Pharmaceutical/Biotech — Remote (UK) - Multiple Positions Consultant and Senior Consultant Roles available. Package: Excellent Hourly Rates (£75-£100 p/hr) or Salary (£60k- £90k) offered in-line with Experience The Role in 20 Seconds You've spent a decade or more in pharmaceutical IT quality, validation, or GxP compliance. You've probably held titles like Validation Manager, QA Lead, CSV Lead, or IT Quality Manager — in a pharma sponsor, a biotech, a CRO, or a specialist consultancy. You know how to walk into a mid-size biotech on a Monday morning, pick up a statement of work, and get on with it. Our client is a specialist GxP and CSV consultancy that runs entirely on senior people. No juniors. No box-ticking. Their clients want experience and guidance. If that sounds like the kind of place you'd actually want to work, keep reading. The Company A lean, specialist consultancy delivering GxP compliance and CSV services to a client base predominantly in the USA, EU and UK. Their clients range from pre-revenue biotechs building their first quality management system to more mature pharma companies requiring specialist expertise for regulatory remediation, system validation, and audit programmes. They are mostly small to mid-sized clients with exciting product portfolios, generally in the "30–200 employee" range. These are organisations sophisticated enough to know exactly what they need, but lean enough that they don't have the internal QA resource to do it themselves. That's the gap this consultancy fills, and it's why the work is genuinely interesting rather than purely procedural. The model is deliberately small. Only experienced consultants are deployed. The quality of the work product is the commercial proposition, which means the people doing it have to be good. There's no layer of management between you and the client, and no junior to pass the awkward bits to. Some people find that energising. Those are the people we're looking for. The team is small, friendly, and above all, hardworking. They all share the same work ethic, and they are enjoying rapid growth - hence the reason for hiring. What You'll Actually Do The bread and butter: • Lead validation projects end-to-end — or execute defined work packages within them, depending on where you sit, • Plan and conduct GxP vendor audits of technology providers, from agenda to audit report to corrective action closure, • Author and renovate SOP suites, data integrity policies, change control frameworks, and vendor qualification programmes, • Deliver gap analyses and inspection readiness support that actually prepares people, rather than producing a report that sits in a drawer, • Act as the primary client contact on engagements — chairing meetings, managing stakeholder relationships, and presenting findings to senior quality and IT leadership The less obvious bits that matter as much: • Having the confidence to push back on a client when something is wrong — and the judgment to know when to pick that battle, • Translating complex regulatory requirements into proportionate, practical actions without gold-plating and without cutting corners, • Keeping an engagement on track and within budget whilst also managing the client expectations Who We're Looking For You'll be a natural fit if: • You've come up through pharmaceutical quality, validation, or IT compliance — in a sponsor, a biotech, a CRO, or a consultancy — and you've genuinely owned deliverables, not just contributed to them, • You're the person colleagues come to when there's a regulatory question that actually matters, rather than one that can be answered by reading the SOP, • You ask smart questions early rather than making assumptions, and your documentation doesn't come back needing heavy rework, • You're comfortable working independently in a remote model with real deadlines and defined accountability, • At the senior end — you've been the responsible professional when a regulator walked in, and you know exactly what that feels like Essential: • 10+ years in pharmaceutical quality, validation, or GxP compliance in a regulated environment, • Hands-on experience with computer system validation or quality assurance — in a pharma, biotech, or CRO setting specifically, • Proven ability to write inspection-ready documentation: validation plans, risk assessments, qualification protocols (IQ/OQ/PQ), and audit reports., • High degree of working familiarity with GAMP 5 concepts (software categories, V-model, risk-based testing) and key regulations such as ICH E6(R3), EU Annex 11, 21 CFR Part 11, and the FDA Computer Software Assurance (CSA) Guidance, February 2026., • Right to work in the UK without sponsorship Nice to have: • Previous experience in a client-facing consultancy role as opposed to purely in-house, • Inspection experience with FDA, MHRA, or EMA involving computerised systems, • Familiarity with eQMS implementation, data migration validation, or AI/ML in a GxP context, • RQA, ISPE, or DIA involvement, • ISO 27001 awareness or Lead Auditor certification. What's Actually In It For You The practical stuff: • Rates/salary based genuinely on experience — we won't be trying to lowball you at interview, • Remote working as the default — occasional client site visits, planned in advance, • Contract or permanent — both considered depending on what works for you, • Fractional engagements across multiple clients usually 1-2 month assignments The things that don't show up in a rate card: • Clients who are building something — clinical-stage biotechs constructing their quality infrastructure from scratch as they advance through trials, not large pharma running the same validation cycle they've run for twenty years, • Direct relationships with QA Directors, heads of IT, COOs, and occasionally CEOs — because with staff rosters of 30–200 people, that's who you're talking to, • A client list where your name is on the work, not buried four layers down in a consulting pyramid, • No internal politics to navigate — small team, clear accountabilities, • The satisfaction of handing over something that will genuinely hold up under inspection The Honest Bit This is not a nine-to-five with a clear desk at five. Client deadlines are real, inspection windows don't move, and occasionally a deliverable needs to be right by Friday regardless of when it landed in your inbox. Remote working in a fractional/contract model requires genuine self-management — there's no office to walk into and no one tracking your hours, so the only thing that matters is whether the work is good and the client is happy. If you've spent your career in large pharma with a lot of internal support around you, the step to a lean consultancy model can be bigger than it looks. If you've done it before, or if the idea of that autonomy is what's been missing from your current role, you'll probably love it. 📧 Apply via the link, or message Andy Clarke directly if you want to talk it through first — especially if you're weighing up the contract versus permanent question, or not sure whether your specific background is the right fit. 💼 Andy has been in and around regulated life sciences for over two decades. You'll get a straight answer to a straight question, not a sales pitch. All applications are treated confidentially. Guess what... We're not only interested in the conventional CV. Spent fifteen years in-house at a pharma and want to move to consultancy? Coming from a CRO and want to work across a broader client base? Built your validation knowledge in a regulatory technology company rather than a sponsor? Get in touch. If the experience is real and the documentation quality is there, the background matters less than you might think.

AssureBio is supporting a globally established pharmaceutical organisation in the appointment of a GVP QA Manager to strengthen its R&D Quality Assurance function. This is a high-impact role focused on pharmacovigilance quality oversight, vendor governance and regulatory inspection readiness within a global environment. You will operate as a key Quality Subject Matter Expert, ensuring robust compliance, patient safety and proactive regulatory readiness across pharmacovigilance and wider GxP activities. The position offers strong cross-functional exposure, working closely with senior stakeholders, global partners and regulatory bodies. Key Responsibilities GVP & R&D Quality Oversight • Provide leadership across pharmacovigilance QA activities within R&D and Scientific functions, • Act as SME for GVP/GxP compliance and provide expert regulatory interpretation, • Maintain oversight of Pharmacovigilance System Master File (PSMF) integrity, • Support quality due diligence for new product opportunities Audit & Vendor Management • Develop and maintain the R&D audit schedule, • Lead internal, vendor and third-party audits (acting as Lead or Co-Auditor), • Oversee quality performance of PV vendors and service providers, • Ensure effective audit closure and CAPA tracking Inspection Readiness & Compliance • Support regulatory inspection preparation and hosting (MHRA, EMA, FDA and global authorities), • Lead CAPA management arising from inspections and audits, • Provide risk-based QA advice to cross-functional teams, • Review and approve deviations, change controls and quality events Quality Systems & Continuous Improvement • Generate and present R&D quality metrics to senior stakeholders, • Deliver GxP training and guidance across the organisation, • Maintain awareness of evolving regulatory expectations and ensure business readiness, • Support continuous improvement of quality systems and processes This role is central to ensuring high standards of pharmacovigilance compliance, vendor oversight and inspection readiness across a complex global environment. Experience & Qualifications Essential • Scientific degree (Pharmacy, Chemistry, Biology, Engineering or related) or equivalent experience, • Significant QA experience within pharmaceutical and/or medical device environments, • Strong expertise in Good Pharmacovigilance Practice (GVP), • Proven experience supporting regulatory inspections and PV teams, • Experience in auditing, CAPA management and quality systems oversight, • Ability to operate autonomously and make risk-based quality decisions Desirable • Certification in auditing or Quality Systems Management, • Working knowledge of Good Clinical Practice (GCP), • Experience managing PV vendors and service providers, • Strong stakeholder engagement and influencing skills Candidates must demonstrate the ability to operate independently, provide strategic quality input and maintain strong regulatory compliance across global PV operations.

Baltic Recruitment are delighted to be continuing our partnering with OsecoElfab, a global manufacturer specialising in engineered rupture discs and explosion venting solutions for high-hazard industrial environments to assist with their search for a Quality Systems Engineer. Read on to fully understand what this job requires in terms of skills and experience If you are a good match, make an application. Overall Purpose: • The Systems Quality Engineer plays a pivotal role in fostering excellence by overseeing the development, implementation, and continual enhancement of quality management systems and standards throughout the organization., • This role involves ensuring adherence to company procedures and spearheading initiatives to drive continuous improvement championing a culture of quality across all facets of the business., • Collaborate closely with the Quality team and company stakeholders to establish, monitor, and implement the Quality Management Systems (QMS) and contractual/legal governance such as PED 2014/68/EU., • Devise, refine, and enhance the Integrated Management System to serve as a foundational framework that promote quality and operational standards., • Evaluate potential quality risks and opportunities, and escalate them when deemed appropriate, facilitating timely intervention and resolution., • Act as the company representative for notified body and customer audit visits., • Manage and deliver both the internal and supplier audit schedule, leading on any non-conformances, ensuring that corrective and preventative actions are effectively executed, and outcomes are effectively communicated., • Safeguard the integrity of quality systems implementing and scrutinizing compliance with ISO 9001, PED, ASME and ATEX., • Play a pivotal role in overseeing the supply chain by conducting audits and reviewing operational practices and systems to ensure compliance with our QMS Standards., • Act as a focal point for the training and professional development of all staff members, guaranteeing their comprehensive grasp of quality standards and their direct relevance to overarching business objectives., • Ensure that material conforms to statuary regulations for use within rupture disc manufacturing., • Bachelor's Degree (or equivalent qualification/experience) in relevant technical field., • Trained auditor., • Proven expertise in precision engineering and manufacturing environments., • Demonstrated experience in establishing and maintaining robust quality systems across manufacturing and engineering businesses., • Proficiency in change management complemented by strong analytical skills., • Accomplished at nurturing and maintaining client and stakeholder relationships., • Exceptional multitasking skills coupled with the ability to efficiently prioritize workflow., • Proficient and clear communication skills, both verbal and written., • Proficiency in utilizing Microsoft Office tools such as Excel, Word, PowerPoint, and Outlook., • Familiarity with business systems such as ERP (e.g. Microsoft Dynamics)., • Accomplished presentation skills., • Understanding of standards like PED, ASME, and ATEX (equivalent technical standards considered as training will be given)., • Proficiency in root cause analysis techniques including FMEA (Failure Modes and Effects Analysis)., • Familiarity with requirements including APQP (Advanced Product Quality Planning), PPAP (Production Part Approval Process)., • Competitive salary on offer, depending on level of experience., • 37.5 hours per week, Monday-Friday., • Company pension scheme., • Private health care., • Life assurance., • Quarterly bonus scheme potential. xrnqpay, • Additional benefits.

Audit Senior – Newcastle Newcastle Hybrid & Flexible Working Competitive Salary + Benefits We’re recruiting an Audit Senior in Newcastle on behalf of a well-established and growing accountancy practice. This is an excellent opportunity for a part-qualified or qualified auditor to take ownership of engagements, build strong client relationships, and play a key role in supporting and developing junior team members within a collaborative audit team. The Role As Audit Senior, you will be responsible for leading audit assignments from planning through to completion, working closely with the Audit Manager and Partner. Your responsibilities will include: • Completing audit planning documentation, • Agreeing audit timetables with the Audit Manager, • Briefing, training and debriefing Audit Assistants, providing formal feedback where required, • Liaising with client staff on-site, building effective and professional working relationships, • Monitoring budgeted versus actual time, identifying scope changes, on-site issues, and overruns, and reporting these promptly to the Audit Manager, • Keeping clients informed of progress and key issues while maintaining strict confidentiality, • Auditing draft tax computations and tax provisions, liaising with internal tax specialists where required About You You will be ICAEW, ICAS, or ACCA part-qualified or fully qualified, with experience gained within a UK audit and accounts practice. You’ll demonstrate: • The ability to lead your own work and take responsibility for your professional development, • Excellent communication skills, with the confidence to positively influence colleagues and clients, • Strong organisational skills and the ability to manage multiple deadlines, • A proactive and solution-focused approach What’s on Offer Hybrid and flexible working arrangements Exposure to a varied and interesting client portfolio Opportunity to lead audits and mentor junior staff Supportive and collaborative audit team Competitive salary and benefits package Location NewcastleCommutable from Gateshead, North Shields, South Shields, Sunderland, Durham, and surrounding areas Apply For a confidential discussion or to apply, contact Jack Wood at or .

Following a recent review of the finance department this established group of companies is seeking to strengthen the team by appointing a Senior Financial Accountant. Operating through several divisions and with turnover in excess of £100m, they have enjoyed impressive growth and expansion and have recently become part of a global company. The successful candidate will be joining the business during an exciting period of change and integration, part of which will involve transitioning over to a new ERP system and the development of more robust controls, reporting and analysis processes. The ideal person will therefore have a good amount of experience in corporate financial reporting, control and compliance, with expertise in IFRS and UK GAAP. A key part of this role will involve working with and developing high performance teams whilst driving accountability and continuous improvement with colleagues on site and stakeholders internationally. Main responsibilities:Supporting the development of best in class financial reportingIFRS group reporting and consolidationsUK GAAP statutory reporting (FRS 101 / FRS 102)Month-end and year-end close ownershipCross-functional stakeholder engagementExternal and internal audit coordinationFinancial controls and process improvementTechnical accounting and policy implementation Desired candidate profileStrong, credible presence with the ability to motivate and mentor teamsRapid learner who quickly adapts to new systems, regulations, and business modelsCommercial awareness with excellent analytical and problem-solving capabilityHigh attention to detail with strong governance / compliance mindsetConfident communicator across all organisational levelsStrong financial accounting / technical pedigreeFully qualified Accountant (ACA / ACCA preferred) Based at their modern premises this would be a great opportunity for an accountant / auditor from practice seeking to move to industry or an experienced financial accountant. The role will be office based and offers a range of attractive benefits. JBRP1_UKTJ

If youre a Food Safety Auditor who knows BRCGS inside out and thrives on driving standards, this is your opportunity to take ownership of the internal audit programme across a busy manufacturing operation. Reporting to the Technical Manager, this is a critical role in protecting compliance, strengthening safety culture and supporting continuous improvement across multiple sites Whats in it for you • Salary of £35,000 - £40,000 + Benefit Package, • High-visibility role within the Technical team, • Full ownership of the internal audit programme, • Direct exposure to BRCGS and major retailer standards, • Involvement in external audit hosting and retailer engagement, • Leading and conducting internal audits to verify compliance with company policies, BRCGS and retailer standards, • Managing and maintaining the internal audit schedule across QMS and retailer requirements Identifying non-conformances, logging them electronically and driving corrective and preventative actions, • Assigning actions and deadlines to relevant stakeholders and tracking closure, • Communicating monthly audit updates to senior management, • Supporting GAP analysis against new versions of standards, • Food Hygiene Level 3 minimum, • HACCP Level 3 minimum, • Proven experience in food manufacturing, • BSc in Food Science, • Strong working knowledge of BRCGS and UK legislation, • Experience with UK retailer standards (e.g. Tesco, Lidl), • Internal auditing qualification, • Strong analytical skills with the ability to identify root causes and trends JBRP1_UKTJ

The JobA Group Accountant & Consolidation Manager will be hired for a period of 6 months to strengthen the team.Key Areas of Responsibility: • Group reporting and consolidation - prepare monthly and quarterly consolidated accounts, • Shareholder and executive reporting -support the production of shareholder, executive and board reporting, • Statutory and external reporting - assist in preparing statutory and interim financial statements, • External audit - support external audit processes, including evidence collation and responding to auditor queries, • Financial controls and governance - ensure compliance with internal policies, identifying any areas for improvementThe businessAn international and complex businessAbout You, • Fully qualified accounting ACA, ACCA, CIMA or equivalent, strong technical grounding on IFRS, • Advanced excel skills, • Consolidation accounting, ideally with an international, complex organisation, • Experience with consolidation systems, • ERP experience

Job Description Role: Auditor Pay: £150 a dayplus benefits Location: BL Work postocdes • We are seeking an energetic, organised, and customer-focused team member to join our growing Water Efficiency team., • This hands-on role involves visiting customers homes to install water-saving devices, resolve minor internal leaks, and provide tailored advice on reducing water use., • There is also option to work in a non household role with less canvassing, • The ideal candidate will have a proactive, can-do attitude, excellent communication skills, and the ability to manage their own workload to meet installation and service targets., • Water Saving Device Installation (light-touch), • Leak Detection & Minor Repairs, • Customer Engagement Advice, • Home Water MOTs, • Project Delivery and Target Achievement, • Install light-touch water-saving devices in customers homes, • Identify and repair minor leaks within your training remit, • Carry out Home Water MOTs, including meter readings, flow rate tests, and leak checks, • Provide tailored water efficiency and behavioural change advice to customers, • Manage daily appointments using the project CRM system and ensure timely, high-quality completion of work, • Maintain accurate stock levels and follow all Health & Safety guidelines JBRP1_UKTJ