Play a figurehead role in managing regulatory agency inspections from MHRA, EMA, and FDA. * Oversee a global electronic Quality Management System along with managing a network of CMOs. * Lead Quality ...
Ensure compliance to the relevant company SOP & current MHRA & EU GDP requirement * Participate in resolving quality matters with contract manufacturers * Participate in resolving supply chain ...
Understand the role of the MHRA (and other competent authorities) in the licensing of medicines, the risk-based inspection process, the role of the enforcement group, the Inspection Action (IAG) and ...
Up-to-date knowledge of the ABPI, PAGB codes, MHRA and other relevant international regulatory bodies * Understanding of the NHS/ international health systems and broader health environment
EU and UK product labelling approval and compliance with the MA approval activities. * interact with the MHRA and any EU UK Regulatory Authority. Ensuring that regulatory processes are completed and ...
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Previous involvement in a regulated laboratory atmosphere (like MHRA GCP for laboratories, GLP, or GMP). * Proficiency in operating and resolving issues with ELISA analytical systems. * BSc Science ...
Knowledge of GMP and GDP and MHRA Guidance Note 14 * Practical experience in GxP Supply Chain, Production and Quality Assurance * Pro-active and solutions-driven, with the ability to work to strict ...
... MHRA, audit, release
... MHRA/GCP/ICH requirements. * Prepare Investigational Product Review Forms (IPRFs) and submit them to WEP Clinical Regulatory team. * Support preparation of study files based on project scope ...
Previous experience supporting regulatory inspections (MHRA, FDA) * Operational experience within a Pharmaceutical manufacturing or laboratory setting is desirable What we offer you * A competitive ...
Key Words: Analytical Development | Method Development | Assay Development | MDV | Protein Characterisation | Product Characterisation | Protein Analysis | AAV | Viral Vector | Gene Therapy | GMP | QC | Quality Control | CMC | Biologics | Biopharmaceutical | C> | ATMP | Analytical Chemist | Senio...
Based in the heart of the technology hub of England, Shoreditch, Montash has over 18 years of experience in the professional services sector.We place highly qualified technology talent into the international market, supporting clients to grow and develop their technical projects.Montash is lookin...
At Pareto, we have range of entry level graduate schemes where we deliver award winning training and you reap the benefits. Fact Number 2 – There is an abundance of fantastic graduate opportunities in Manchester, and a candidate driven marketplace means that you’re in a stronger position than eve...
To assist or host when required: - * Regulatory inspections (MHRA); * Client audits Process: * Lead and participate in all on site operational processes, as needed or as applicable. * To maintain ...
Supply Chain Manager Kent (Hybrid) 15 minute walk from Dartford Train Station Pharmaceutical Company Job Purpose Management of the supply chain for UK and International markets and relationships with our partner contract manufacturing organisations (CMO) and distribution service organisations (4P...
They are on the lookout for a Lab Technician who will be responsible for assisting with process development activities and GMP shipments, ordering consumables and reagents for PD and GMP. Maintain a clean and orderly laboratory. ...
Proven experience working as a lab technician in a molecular biology laboratory. Knowledge of laboratory safety protocols and the ability to work in a controlled laboratory environment. We are looking for immediately available lab technician either a MSc with some industry experience or someone w...
Graduate level opportunity in a performance based role in the Global Heavy Infrastructure space in the US Market, based in Surrey. OTE £100K + ( excellent commission scheme pays up to 50%). ...
Key words: LC-MS, GC-MS, LC-MS/MS, GC-MS/MS, mass spectrometry, chromatography, triple quadrupole, laboratory, analytical chemistry, method development, method transfer, biological samples, urine, oral fluid, hair, toxicology, bioanalysis, forensics, drug. You will be responsible for the entire a...