Manager, Commissioning & Qualification (f/m) 100%
Posted on May 8, 2022 by Michael Bailey Associates - UK Contracts
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)
- 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.
(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
- 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.