Quality Assurance Manager
Madrid, Spain
hace 2 días

Key Accountabilities

  • 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 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.
  • Job ID R0013889

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