Quality Assurance Engineer – Pharma Manufacturing (5197)

Quality Assurance Engineer – Pharma Manufacturing – 5197 URA

Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a German speaking Quality Assurance Engineer on a contract based in the Schaffhaussen area.

Main Responsibilities:

• Represent QA Engineering in assigned qualification projects in the company.
• Assure projects on qualification aspects in Pharma-/Chemical- and Solids-Manufacturing, in Optical Inspection, Device Assembly Packaging and Warehouses, all including Utilities, Monitoring systems and HVAC systems are compliable to internal and external requirements/guidelines.
• Support QA Engineering in all aspects where needed depending on individual qualification.
• Adherence to the above mentioned Adherence to all quality systems
• Compliance with the GMP, EHS and SOX requirements and guidelines, which are connected to the respective function.
• Support the qualification aspects of technical projects, assosiated with the entire life cycle of the system, implementation, testing/qualification and ongoing support, such as conducting appropriate event impact assessments, evaluating changes, up to the final retention period of records in the areas as mentioned in chapter 1
• Assure review for compliance and approval of all critical qualification deliverables / documents (e.g. QP, URS, eFMEA, DQ, IQ, OQ, PQ, QSR & PM-Plans) in all areas mentioned above.
• Provide input and supervision for appropriate qualification projects according to the current training status.
• Provide input and support to measuring device qualification and their life cycle
• Provide input and support to risk management system, such as eFMEA
• Continuously observe, communicate and implement pro-actively possible areas for improvement
• Attend trainings relevant to the successful execution of the function
• Keep up to date of the current international industrial standards and new developments

 Qualifications and Experience:

•  Relevant working/residency permit or Swiss/EU-Citizenship required.
• MSc (ideally) or BSc in a related field
• At least five years of experience in a similar role in the pharmaceutical industry are a mandatory requirement
• Fluent German is mandatory for the position
• Flex model of work: 3 days at site, 2 home office (if the project allows it and upon agreement with the line manager)