Quality Assurance Manager応募後で応募 求人ID R0013889 掲載日 11/07/2019 Location:Madrid, Spain
- 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.
- At least 1 year of experience as Qualified Person
Skills and Competencies
- Knowledge ofaseptic 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.