Job Description
Cleaning Validation Specialist required for a Pharmaceutical organisatioin to work in the facilities Validation department to support cGMP manufacturing activities so you will be responsible for ensuring compliance to the cGMP guidelines on Validation activities.
My client is an industry leading organisation with a fantastic reputation and friendly team. This company is a specialist in developing new vaccines, therapeutic proteins and enzyme products, and they also manufacture their own licensed biopharmaceutical products
Key responsibilities:
*Manage, execute and deliver Cleaning and Process Validation projects
*You will be liaising with the Engineering, Production, QC and QA departments to ensure a timely delivery of the qualification report
*Design and optimise Cleaning -in-place processes
*Generation of validation documentation in accordance with the full validation life cycle for equipment, utilities and facilities.
*Writing, reviewing and approving validation protocols
*Follow up and resolve discrepancies, CAPAs and non-conformances
Candidates Criteria:
*Educated with a Life's Sciences degree or equivalent
*Previous knowledge of Biopharma processes and or Validation life cycle documentation
*Experience of using APISciex LC-MS/MS equipment & software
*Experience coordinating validation or manufacturing Cleaning activities
*Experience of dealing with internal customers, identifying and taking the lead in delivering work programmes, reporting progress, dealing with issues to ensure customer satisfaction
Get in touch with Fareen Choudhry for more information: / 01737 236 737
Keywords:
process validation / clean room / CAPA / protocols / GMP / QA / QC / Engineering / biopharma / biologics / microbiology / molecular biology / biopharmaceutical
