Tasks

  • Assist the Product Quality Leader (PQL) in implementing the overall product quality strategy
  • Lead and support supplier qualification and requalification processes, including conducting external supplier audits as applicable
  • Draft and approve technical quality agreements (QTA) and ensure process compliance within the area of responsibility
  • Evaluate deviations, investigations, product quality complaints, out-of-specification (OOS) results, and corrective and preventive actions (CAPAs); support change control processes for assigned products
  • Serve as the primary contact for quality-related topics with partner or supplier organizations
  • Establish, update, and maintain GMP/GDP-related Quality Management System (QMS) documents
  • Support departmental and cross-functional compliance initiatives
  • Assist in hosting Health Authority or partner inspections at supplier sites or at the company
  • Support the EU Qualified Person in relevant matters

Qualifications

  • Minimum of 5 years of experience in the pharmaceutical industry, with at least 3 years in a GMP Quality Assurance role
  • University or master's degree in pharmacy, chemistry, or a related field
  • Working knowledge of GMP/GDP legislation
  • Familiarity with sterile manufacturing and product development processes
  • Experience in cross-functional teamwork
  • Ability to work both independently and collaboratively; well-organized and structured
  • Excellent communication and presentation skills at various organizational levels
  • Fluency in English, both written and spoken; proficiency in additional languages is beneficial