Technical QA Manager

vor 2 Monaten

Basel, Schweiz FLEXSIS Vollzeit
EINFÜHRUNG:
As a preferred supplier for F. Hoffmann - La Roche Ltd. in Basel, we are looking for a motivated

Technical QA Manager (m/f/d)

This is a full-time position, with a 12-months duration with possible extension. The earliest start date is as soon as possible. Home Office is allowed on a case by case basis.AUFGABENBESCHREIBUNG:
  • Support of end to end cGMP activities, in maintaining the Right to Operate at the Swiss Technical R&D sites and in ensuring quality and compliance of IMP products according to Health Authority requirements and Company Standards for IMP products.
  • QA supervision of qualification- and validation-activities for GMP-relevant equipment for Synthetic Molecule production and Biotech production
  • Responsible to ensure QA oversight and setting guardrails for the operation facilities regarding GMP and Quality standards
  • Support of implementation of DI requirements
  • Provide sound technical and quality assurance expertise for review and approval of quality related documents (e.g. Deviation records, CAPAs, SOPs, Risk Analysis etc.)
  • Performing deep root cause analyses as a facilitator or expert to address and investigate complex problems independently
  • Responsible for driving and optimization activities and improvements within IMP Quality Operations Switzerland
  • Partner with stakeholders and provide guidance to ensure successful delivery of the IMP goals
  • Represent and support your area of responsibility at HA inspections and internal audits
ERFORDERLICHES PROFIL:
Must Haves:
  • Academical degree in Engineering, Chemistry, Life Science, Pharmacy or equivalent
  • Min. 10 years experience in the pharmaceutical industry with 5 years of Quality Management related experience in the pharmaceutical industry
  • Experience in Qualification/Validation of Small Molecules, in addition of Biotech Molecules
  • Sound understanding on current DI (Data Integrity) requirements
  • Profound knowledge of global quality and GMP requirements
  • Strong team-player with a high level of self-motivation and the ability to effectively influence others across all levels of the organization
  • Successful performance in health authority inspections and internal GMP audits
  • Fluent German and English (spoken/written) is a must for this position

Additional Skills:
  • • Great communicator to stakeholders and in the team
  • • “Can-Do” attitude and self-confident to take over new responsibilities and tasks
  • • Ability to speak up, listening to other opinions and able to rethink the own way to ensure a highest level of success
  • • Knowledge of Pharmaceutical Development and about the special needs and road blocks regarding GMP-compliant production


Application process
Interested? You can find more information here:

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