Why work for this company?
Our client discovers, develops, manufactures and commercialises medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services. They serve veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries.
- 65+ years of experience in animal health.
- Nearly $6 billion annual revenues.
- 25 manufacturing sites around the world.
- 10,000 employees worldwide of which 1,100 employees are committed to R&D.
The QC Data reviewer is responsible for peer review of Laboratory test data, GMP documentation and ensuring that the data review in the group is prioritised to meet required time lines.
Duties & Responsibilities
- Evaluates laboratory data for compliance with analytical methods and SOPs and to GMP.
- Review of laboratory raw data from in process, batch release and stability studies against test method requirements and specifications to strict time lines.
- Review of stability raw data and reports against relevant test methods, protocols and procedures.
- Review/ Preparation of batch release, in process and stability trend data.
- Reviews sample results for completeness and accurate representation of the data and report findings.
- Communicates with laboratory staff to proactively address the quality of laboratory documentation.
- Supports the training of laboratory staff on compliance and data reviews. Administering Good Documentation.
- Practices training and ensuring that proper GDP training is understood and followed by lab staff.
- Conducts SOP review and writing.
- Reviewing and suggesting improvements to processes and procedures for Quality Control function.
Qualifications, Experience, Skills
- At least 3 years Biotech/Pharmaceutical QC experience with a strong knowledge of cGMP.
- Strong knowledge of cGMP and cGLP, and of good documentation practices.
- Understanding of chromatography principles and data. Other techniques are also beneficial including CE-SDS, ELISA testing, protein quantification methods.
- Excellent interpersonal and communication skills, meticulous eye for detail.
Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003...