QA Manager Drug Product (m/f/d)

  • Advanced University degree in Pharmacy (preferred), Chemistry or alternative technical / science university degree
  • Minimum of 5 years' experience in different positions like pharmaceutical or chemical development, quality control, analytical development, chemical or pharmaceutical production or similar operational positions in the pharmaceutical industry
  • Minimum of 3 years' experience in quality assurance of drug product covering also combination products
  • Excellent knowledge of GMP and GDP requirements, ability to interpret and implement quality standards
  • Sound knowledge of drug product manufacturing, control, packaging and distribution procedures
  • Providing GMP/GDP expertise thus ensuring that medicinal products are developed, manufactured, packed, labelled, distributed and controlled in accordance with regulatory expectations and applicable quality standards
  • Performing GMP onsite audits at Contract Manufacturing Organizations (CMOs)
  • Preparing GMP/GDP Agreements in collaboration with CMOs and the CMC team
  • Executing QA activities to support release of active ingredients, investigational medicinal products including approval of master process documentation, batch record review, resolution of investigations, and assessment of change controls
  • Establishing a quality risk management approach in projects based on ICH Q9 concepts to ensure that quality is understood and managed by all stakeholders throughout the product life cycle

» Job description

nemensis ag
Raum Basel [CH]