Batch record review and batch disposition of clinical trial and commercial medicinal products.
Management of Deviations, 00S and related CAPAs. Collaborate in all quality events, Change Control implementation, Claims and recalls.
Review and approve SOP and related GMP documents.
Contribute to the compilation of data for the Operational Review Board meetings and Annual Product Review.
QA Liaison to other teams.
Shop floor QA activities to support the process.
Education and experience
Degree in Pharmacy. Postgraduate studies are an asset.
At least 2 years prior experience in a GMP certificate pharmaceutical or biotech company, in the qualified deputy position or experience in the analysis of Medicinal Products and Active Ingredients.
Ability to operate independently, being flexible and set own agenda, but also to work as part of a team.
Skills and Competencies
Knowledge of aseptic processing in cleanroom environment.
Tidy, neat and organized, attentive to detail.
Ability to read, write and speak English fluently and to communicate effectively
General experience working with computers at user level, including MS Word, MS Power point and MS Excel.
Good interpersonal skills
Flexible working attitude, open to changes.
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