Senior QA Manager
ProClinical Recruitment
Zug
vor 18 Tg.

ProClincial is working with a global specialty pharmaceutical company that is seeking a Senior QA Manager to be based in Zug, Switzerland on a permanent basis.

This Senior QA Manager job would suit an experienced individual to join the company's QA team. This opportunity presents a unique challenge to leverage the well-

established heritage of these drugs while simultaneously building a new, unique culture focused on growth, profitability, and long-

term vision. What you can expect from this role is the opportunity to work in a start-up type environment where your position will be broad, communication between departments is fast and effective and you will have significant responsibility and autonomy for your work and contribution.

Job 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
  • Skills and Requirements :

  • 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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