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

Michael Bailey Associates - UK Contracts

Posted on May 8, 2022 by Michael Bailey Associates - UK Contracts

Bern, Switzerland
Research
1 Jun 2022
Annual Salary
Full-Time

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.

Reference: 1589835813

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