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QA Specialist Batch record review / Dossier compilation

For this project We are looking for a QA specialist with extensive experience with batch record review & dossier compilation in the context of GMP manufacturing

Job Description

The Quality Assurance department at our client Janssen Vaccines & Prevention (V&P) in Leiden is a fast-developing department. Janssen is currently working on a full Vaccine pipeline, including a COVID-19 vaccine developed at their site in Leiden and by external collaborations. The QA team is responsible for overseeing and supporting the quality systems, projects and facilities. In light of their covid-vaccine project they are looking for temporary assistance from an experienced QA specialist who ill take on the following responsibilities;

Responsibilities

  • Batch record review of manufacturing documentation. Ensure that all operations meet cGMP requirements;
  • Batch dossier compilation & certificate preparation in collaboration with the Qualified Person and Operations department;
  • Reliable review and release of raw materials that are needed for the manufacturing process;
  • Issue management in collaboration with production and support departments. On the shop floor support where necessary;
  • Represents the Quality department in operational meetings when needed;

Requirements

  • MSc in a scientific discipline e.g. Pharmacy or Bio-Pharmaceutical Sciences;
  • 5+ years of quality assurance/quality control experience in a pharmaceutical GMP setting, by preference vaccines;
  • Solid experience with GMP-standards;
  • Has experience with review activities of manufacturing documentation (batch records) in a regulated environment;
  • Preferably has knowledge and experience with cell culture, purification processes, operations and business processes within a GMP environment;
  • Independent and organized accurate worker, with eye for detail;
  • Is pro-active in the identification of issues, has problem-solving capabilities, and timely implements solutions;

Benefits

  • Contract: temporary project through Oxford for 3-6 months;
  • Salary: €3500- €4800 gross monthly based on education/ experience;
  • Holidays: 25 (+12)
  • Working hours: full-time, 32 hours discussable
  • Region: Leiden
  • Vacancy number: 17245

Oxford Global Resources is the largest recruitment agency within the fields of Science, Engineering and IT. All our recruiters have a relevant background within these fields and can help you find the perfect job through our extensive network.

As a specialist company we have a wide range of laboratory vacancies in Quality Control (QC) and Research & Development (R&D) within various sectors, including Pharmaceuticals, Biotechnology, Contract Manufacturing, Contract Research, Food Industry, Chemicals, Environment and Plants.

Oxford is always looking for talent with expertise in Biotechnology, Immunology, Biochemistry, Virology, Microbiology, Molecular Biology, Life Science, Analytical Chemistry, Physical Chemistry, Polymer Chemistry, Petrochemistry and Diagnostics. We are keen to meet candidates who have experience in one or more of the following techniques: USP (Upstream Processing) DSP (Downstream Processing), Bioprocesses, virus culture, cell culture, ELISA, FACS, Western Blot, SDS-page, PCR, RT-PCR, qPCR, cloning, sequencing, protein purification, purification, HPLC, UPLC, chromatography, physical chemistry, viscosity, melting point, pourpoint, pH, XRF, GC, GC-MS, LC, LC-MS, ICP ICP-MS, AAS, UV, titrations, Karl Fisher, formulation, sterility, determinations, bioburden, environmental monitoring, LIMS, GMP, GLP, GCP, GDP, ISO17025.

Do you find this vacancy interesting? Or are you looking for a position at MLA, HLO, BSc, WO, MSc or PhD and are you interested in the vacancy laboratory Assistant, Laboratory Assistant, Sample Preparation Laboratory Assistant, Analyst, Technician, Assistant Scientist, Associate Scientist, Scientist, Manufacturing Specialist, Process Engineer, Validation Engineer, QA (Quality Assurance) Officer, RA (Regulatory Affairs) Officer, Supervisor, Team Leader, Department Head, Laboratory Manager, Manager, Director, etc. Please contact us directly!