Senior Quality Assurance Specialist

vor 1 Monat

Kaiseraugst, Schweiz Solvias AG Vollzeit

Quality Assurance Manager

We are seeking an experienced Quality Assurance Manager to join our team at Solvias AG. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in our analytical research, development, and manufacturing processes.

Key Responsibilities:

  • Review and approval of SOPs, protocols, reports, Certificate of Analysis, and other quality documents
  • Support quality investigation of deviations and Out of Specification (OOS)
  • Maintenance, recording, and processing of corrective and preventive measures (CAPA)
  • Performing internal audits
  • Organization and management of customer audits and inspections
  • Apply and interpret audit and compliance requirements
  • Act as QA point of contact for customers
  • Support for GMP training

Requirements:

  • Scientific education (Master degree) in analytical chemistry, biochemistry, or life science
  • Multi-year, industrial work experience of 7 years minimum in the analytical-pharmaceutical environment, preferably experience in QA
  • Strong problem-solving skills to meet business objectives
  • Excellent interpersonal skills and teamwork spirit
  • Ability to collaborate in a dynamic, cross-functional matrix environment
  • Broad knowledge and proven experience of the regulatory framework in the GMP environment (ICH, FDA, USP, Ph. Eur.)
  • Solid background in data integrity and computerized systems risk assessment and project support
  • Experience as an auditor is an asset
  • Fluency in English and willingness to learn German is required
  • Flexible work models such as part-time and remote work
  • Minimum 28.5 vacation days
  • Monthly child allowance above the Swiss minimum
  • Voluntary monthly family allowance
  • Various pension fund solutions
  • Daily allowance insurance and non-occupational accident fees paid by Solvias
  • Reka cheques
  • Commuter contribution for using public transport
  • Employee discount programs for fitness, insurance, retail, and more
  • Onsite canteen

Solvias AG offers a dynamic and supportive work environment that allows individuals to grow professionally and personally. If you are a motivated and experienced quality professional looking for a new challenge, we encourage you to apply for this exciting opportunity.

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