Product Manager Quality Control Compliance

Responsibilities

• Ensure analyses of commercial contract products, active ingredients, and raw materials in Quality Control meet pharmacopoeia, regulatory, and customer requirements
• Create and optimize testing protocols, test methods, and specifications for semi-finished goods, active/excipient substances, and packaging materials
• Evaluate and verify compliance with cGMP guidelines during product and raw material analysis
• Assess and resolve analytical problems
• Process complaints, change controls, deviations, OOT/OOS events, and unusual findings
• Plan, supervise, and evaluate ICH-compliant stability studies, compatibility studies, and special studies
• Manage all life-cycle management activities for approved products
• Create documentation for cleaning validation
• Release raw materials

Requirements

• University degree in Pharmacy, Chemistry, or Biotechnology (ideally with a PhD) or comparable qualification
• Professional experience in a GMP-regulated environment and in Quality Control is desirable
• Strong pharmaceutical, analytical, and regulatory (GMP) knowledge
• Project management skills are an advantage
• Strong organizational, problem-solving, and assertiveness skills
• Proficiency in MS Office (Word, Excel, Outlook)
• Very good German and English skills (written and spoken)

Benefits

• Attractive compensation and 30 days of vacation
• Modern in-house canteen with attractive subsidies
• JobRad leasing
• Corporate Benefits: Exclusive discounts at numerous well-known brands
• Good transport links and free employee parking
• Free company sports (e.g., badminton, football, and fitness courses)

About the Company

Simtra is a premier contract development and manufacturing organization that has been bringing sterile, injectable medicines to market for over 65 years in collaboration with more than 60 international customers worldwide. Our focus is on the manufacture of cancer therapeutics.