Lab Support is currently recruiting for a Senior Quality Officer to work on a permanent basis for their client based in Suffolk. We require a candidate to provide validation support for computerised systems and to carry out qualification and validation activities of both Primary and Secondary pharmaceutical manufacturing operations.
The successful candidate will report to the QA Manager and CSV specialist, building good working relationships across company sites and with third party suppliers.
Main responsibilities will include:
• Undertaking validation duties in compliance with cGMP
• Preparation of CSV documentation, Plans, Reports and Protocols.
• Evaluating change, ensuring validated status of computerised systems and manufacturing equipment is not compromised
• Supporting and qualifying API manufacturing plant, production systems and processes.
• Acting as a Validation Expert for other departments, reviewing and approving protocols and reports across site
• Performing Risk Assessments where necessary
• Participating in audits where required.
Candidates should hold a degree or equivalent in Engineering, or demonstrate equivalent experience, along with proven experience in carrying out quality project work. Experience of Computer Systems Validation work is essential.
Knowledge of industry best practices, e.g. GAMP and ISPE across a range of computerised systems, as well as working with QMS and GMP regulations, is required
Candidates must be strong problem-solvers, with excellent organisational and communication skills.
To apply for this role please call 01223 451021 or email your CV to cambridge@labsupport.co.uk quoting reference number 2183098. Lab Support is unable to employ any candidates requiring a sponsorship to work in the UK and all applicants must be in a position to accept employment without infringement of their immigration status. Lab Support is working as an Employment Agency in relation to this role.