For our client, an international pharma company in Bern, we are looking for a Quality Engineer.



General Information:

• Start date: ASAP / to be discussed
• Duration: 1 year with a possibility of extension
• Workplace: Bern
• Workload: 100%

• Performs system life cycle activities such as periodic access reviews and system audit trail reviews for laboratory equipment
• Coordinates/supports timely and effective completion of QC equipment related investigations, change controls and CAPA’s.
• Performs update of equipment related technical documents such as SOPs, Work-Instructions and forms
• Supports in equipment/system qualification and validation activities

• Extensive technical know-how of QC Lab equipment (computerized and non-computerized) and corresponding system life cycle activities such as periodic reviews
• Min 10 years relevant industry experience.
• Proven experience in equipment system life cycle activities, equipment qualification and system validation in a GMP environment. Good knowledge related to regulatory environments in the life science industry (GAMP 5, 21 part 11,..)
• Experience with processing of QC equipment related non-conformances, CAPA’s and change controls
• Know-how of commissioning, qualification, validation requirements and system life cycle activities according to c(GMP) regulations in a laboratory environment
• Must be well organized, a self-starter, results oriented individual with the ability to multitask in a fast-paced team environment with attention to detail and good documentation practice
• Good verbal and written skills in English, German is a plus.