Manager, Commissioning & Qualification (f/m) 100%

A Biotechnology company is searching for a; Commissioning & Qualification Manager

Overview of position:

• Ensure efficient qualification processes under the currently applicable requirements and recognized industry best practice
• Management of the qualification team (Functional and personnel)

Responsibilities:

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

Requirements:

(Communication & Management experience)

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

(Technical experience)

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

Michael Bailey International is acting as an Employment Agency in relation to this vacancy.