Main Responsibilities:

• Ensure the qualified status of the production site Bern
• Lead and develop staff personnel within the C&Q function
• Ensure consistent documentation quality in support of both CAPEX and OPEX projects.
• Participate in regulatory inspection and response activities.
• Initial qualifications of equipment and facilities (e.g., cleanroom facilities, bioprocess equipment, clean utilities)
• Manage the execution and documentation of functional tests, protocols, and qualifications for new systems
• Complete investigations of process system deviations and implement corrective and preventative actions as required to mitigate future recurrence.

Our Requirements

Management and communication

• Leadership experience
• Consistent communication with staff, supervisors, within the EBSI organization, and with external authorities and partners
• Analytical thinking for problem-solving
• Excellent verbal and written communication skills in English and German

Technical

• University education (engineer, chemist, biologist, or pharmacist) or equivalent.
• Experience in the pharmaceutical environment
• Sound knowledge in the area of plant and room qualifications in the GMP environment
• Experience in quality assurance (GMP) and the necessary qualification and validation procedures (RA, URS, DQ, IQ, OQ, PQ)
• Experience in GEP (Good Engineering Practice)
• Inspection experience in the pharmaceutical field