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Responsibilities and Requirements: .IVD medical devices to support the core team's approved scope of regulatory activities, with focus on instrumentation and software/hardware, and experience in assay development.Demonstrated ability to interface with subject matter experts (SME) and regulatory a...

Collects, process and interpret accurately results, derive conclusions based on sound science, and prepare reports to effectively communicate results and findings to key stakeholders (audience with and without scientific backgrounds). ...

Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems. ...

Job Title: Product Safety Toxicologist Research & Innovation.Product Safety is responsible for the safety evaluation, testing and documentation of raw materials and finished formulations developed by, or acquired by the client in compliance with global regulations and guidelines.The safety testi...

Develop QMS and overall Product Quality Methodology (i.FMEA, dFx, NPI, manufacturing, quality assurance).Develop and implement Quality Documentation Approach, Needs, and Gaps (SOPs, Policies, forms/templates, etc.ISO 9001 Ready/Capable by roughly end of 2024.Support existing team members with tra...

While performing the duties of this job, the employee is regularly required to stand, walk, and sit for extended periods of time.The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.Reasonable a...

Demonstrated experience in managing technology transfers and/or Life Cycle Management projects and investigations. Engineer or Scientist, MSc or equivalent in a technical field (Chemistry, Pharmaceutics, Biological Sciences, Chemical Engineering) with +4 years of experience in biopharmaceuticals,...

Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle as needed for product in-license/due diligence review, product divestment and product withdrawal. Manage execution / authoring o...

Responsibilities and Requirements:.Seeking Supply Chain Planner skilled in Project management to support Client Brand Transition program.Drive global supply chain project management of supply planning activities to implement previous Client to current Client labelling.Collaborate and manage globa...

Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution.You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologi...

Masters of Life Sciences or equivalent, with thorough understanding of scientific principles and at least years of labelling Experience (CCDS / USPI / SmPC) or Bachelor of Life Sciences and at least years of labelling / Regulatory Experience. Drives labelling strategy in partnership with the Glob...

Responsibilities & Requirements: .Client is looking for a consultant who specializes in MES & LIMS sample management module as well as help with a QMS update.The QMS update has no specific timeline .Tulip is MES and L7 need to be done by December.This person would have to have regular meetings du...

Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution.You should have excellent understanding of CFR Part , ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies.Co...

A deep appreciation of Drug safety, FDA REMS program requirements and key processes.Develop and gather the material and guide the Purdue team for the future REMS Inspections.Attend and actively participate on various REMS Consortium meetings and sub teams.Knowledge and some experience in design a...

Perform Analytical Testing: Conduct tests in accordance withTest Methods, Standard Operating Procedures (SOPs), and Pharmacopoeia guidelines (USP, EP, JP).Use at least of the following instrumental techniques: HPLC, Atomic Absorption, Flame Photometry, ICP-MS, and Polarimetry.Solution Preparation...

Responsibilities and Requirements:.Regulatory Affairs product labeling in the pharmaceutical industry.Strong background authoring or updating content and text for CCDSs, EUPIs, USPIs for product labeling from scientific source data and regulatory requirements.Experience with labeling deviations, ...

Science, Engineering or related field with years' relevant experience or MSc with years of relevant experience. ...

Must have 6+ years of relevant experience and a Bachelor's degree in a Science or Engineering related field; or 4+ years of relevant experience with a Master's degree in a Science or Engineering related field. ...

Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle. Prepares documents vital for new product market clearance, approval, and continuance during product life cycle management that includes (but is not limited to) (k)s, PM, De Novo, and technic...

Creates standard and/or custom programs/reports using data analytics tools such as SAS, or other data visualization tools to support data oversight and review by data managers or other data reviewers.Collaborates with cross-functional groups to develop standard and custom data reports for quality...

Our client, a global pharmaceutical organization, has engaged GForce Life Sciences to provide them with a Clinical Programmer. Bachelor’s degree in Statistics, Mathematics, or Computer Science or a related field. Master’s degree is a plus (Biostatistics, Pharmacology, Biology, Biomedical Sciences...

Bachelor's degree, preferably in science, and 6 years related regulatory experience. ...

Expertise in development, validation, and management of the clinical study database throughout its life cycle, from CRF design, database development and testing, discrepancy management, data quality review and database close and lock procedures, CDASH and SDTM data formats. ...

Science, Engineering or related field with 5 years' relevant experience or MSc with 3 years of relevant experience. ...