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QA Specialist (GMP/GDP)

CR/156139_1718038717
  • Negotiable
  • Allschwil, Basel-Country
  • Contract

Are you passionate about ensuring the highest standards of quality in the pharmaceutical industry? We are seeking a dedicated QA Specialist (GMP/GDP) for a 1-year, full-time contract based in Allschwil, Switzerland.

This role offers a unique opportunity to be a key player in the development and pre-commercialisation phases of innovative drug products.

You will be joining a company committed to advancing healthcare through cutting-edge pharmaceutical solutions, working closely with global partners to ensure compliance and excellence in quality assurance. If you thrive in a dynamic environment and have a strong background in pharmaceutical quality systems, this could be the perfect role for you.


Your Role as QA Specialist (GMP/GDP)

  • Manage all activities required for the release of drug substances and products, including approval of process documentation, batch record review, and investigation resolution.
  • Serve as the main QA liaison for development activities, collaborating with partners and overseeing CMOs.
  • Ensure compliance with quality assurance standards throughout the design, development, manufacture, supply, and control of drug substances, products, and combination products.
  • Supervise the GMP/GDP Development QA group within the Quality Assurance team.
  • Conduct quality assessments during supplier/CMO evaluations.
  • Lead issue resolution and QA review for CMC teams and supply chain stakeholders.
  • Initiate and drive quality improvement projects, both internally and through CMOs.
  • Oversee investigations of complaints at the CMO level and ensure timely completion of reviews.



Experience and Qualifications for the QA Specialist (GMP/GDP) Role

  • Advanced university degree in Pharmacy, Chemistry, or a related technical/science field.
  • At least 10 years of experience in pharmaceutical manufacturing, with a minimum of 5 years in Quality Assurance or Quality Control.
  • Proven track record with Health Authorities inspections, risk assessment, and CAPA management.
  • In-depth knowledge of drug substance and product manufacturing at both development and commercial stages.
  • Several years of experience leading cross-functional teams.
  • Comprehensive understanding of (c)GMP/GDP and international regulatory requirements, with the ability to accurately interpret and implement quality standards.
  • Strong interpersonal and influencing skills, with a passion for coaching and personal development.
  • Clear and professional communication skills, both verbal and written.



Apply now for immediate consideration, or reach out directly to explore similar opportunities in the quality sector.

Isobel Abernethy Associate Consultant, Quality Assurance

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