Quality Assurance Expert - Sterile Manufacturing | Quality Assurance Expert - Sterile Manufacturing (all genders)
Merck KGaA
Job Summary
As a Quality Assurance Expert in Sterile Manufacturing, you will join the Site Quality Darmstadt Development team, focusing on parenteral products for clinical studies. Your daily tasks will involve overseeing GMP processes, reviewing SOPs, conducting batch record reviews, and preparing product documentation for Qualified Person (QP) release. You'll act as a shop floor QA, manage deviations and change controls, and ensure compliance with regulatory requirements and quality standards. This role is crucial for implementing new parenteral products and involves supporting audits and inspections, making it an excellent opportunity for a detail-oriented professional passionate about pharmaceutical quality and patient safety.
Required Skills
Education
Master in Biology, Chemistry, other Scientific discipline, or equivalent professional experience, or Approbation as Pharmacist
Experience
- 3+ years of operating experience in pharmaceutical GMP manufacturing of parenteral products
- 2+ years of experience in a pharmaceutical development environment
- Experience in monitoring and evaluation of sterile manufacturing processes
- Experience with methods and concepts of pharmaceutical quality systems
Languages
Additional
- Not specified
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