Ophtapharm AG seeks a Senior QC Method Transfer & Verification Technician in Hettlingen to bridge analytical development and routine quality control, ensuring regulatory compliance and product quality.
The QC Product Transfer & Validation team acts as the critical link between analytical development and routine quality control operations. This position contributes directly to maintaining product quality, ensuring regulatory compliance, and driving operational excellence within the laboratory.
Responsibilities
- Direct method verification and transfer processes for both raw materials and finished goods.
- Conduct analytical testing to support validation efforts, investigations, and change management activities.
- Oversee laboratory investigations, including handling OOX events, deviations, and implementing CAPAs.
- Manage the qualification and full lifecycle of assigned laboratory equipment.
- Draft and review analytical procedures, qualification documents, and standard operating procedures (SOPs).
Requirements
- A degree as a Chemical Laboratory Technician, Chemical Technician, or an equivalent qualification.
- Several years of experience working in pharmaceutical quality control under GMP regulations.
- Strong expertise in instrumental analysis, with a particular focus on HPLC.
- Proven experience in method transfer, method verification, validation, and equipment qualification.
- Fluent proficiency in English.
Nice to have
- German language skills are considered an advantage.
What the company offers
- A pivotal role in supporting new product introductions and analytical method transfers.
- High levels of ownership and autonomy within your specific area of responsibility.
- Close collaboration with experienced colleagues across Quality Control and Operations.
- Short decision-making paths and a pragmatic working environment.
- Attractive employment conditions, an excellent pension scheme, and free parking.
About the company
Ophtapharm AG is an FDA/EU-GMP certified manufacturer specializing in ophthalmic products. The company produces high-quality eye drops, ointments, and gels, which are aseptically produced, filled, and packaged for international markets.
- FDA/EU-GMP certified manufacturing environment.
- Focus on aseptic production of ophthalmic products for global markets.
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.