Sr Quality Assurance Manager - Pharma

03 Jan 2019
03 Feb 2019
Contract Type

Main Responsibilities:

  • Work across all functions to ensure that Quality standards are maintained within the Company
  • Provide quality guidance to product development / tech transfer projects
  • Maintain the documentation system by co-writing and updating quality assurance policies and procedures
  • Propose Risk Evaluation tools and Mitigation Strategies
  • Write/review/approve analytical methods (transfer and validation) protocols and reports
  • Write/review/approve process validation protocols and reports
  • Approve supplier’s CAPAs and deviation reports, change controls, complaints
  • Review and approve batch documentation, and transportation records according to GMP/GDP
  • Support GMP/GDP vendor auditing program

Required Background and Skills:

  • A minimum Master Degree in a scientific field (Pharmacy, Chemistry, Biology)
  • A minimum of 10 years’ experience in pharma/biotech industry (manufacturing, QA/QC) of which a minimum of 5 years in QA
  • Previous operations experience in a manufacturing facility of solid dosage forms and/or injectable is considered a strong plus
  • Previous experience in of Technology Transfer Projects as part of Manufacturing and/or QA Team
  • Team player and excellent communication skills
  • Excellent organizational skills and great attention to details
  • English is the company language

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