Technical QA Manager

vor 1 Tag

Basel, Schweiz TN Switzerland Vollzeit

As a preferred supplier for Roche in Basel, we are looking for an individual

Technical QA Manager (m/w/d)

This is a full-time position (100%) with a 1-year duration and the possibility of extension. The ideal start date is as soon as possible and the latest 01.04.2025. Home Office: Onsite required, home office upon discussion.

AUFGABENBESCHREIBUNG:
  • QA supervision of qualification- and validation-activities for GMP-relevant equipment for Synthetic Molecule production and/or Quality Control
  • 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. Qualification plans and reports, change and deviation management, 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
  • 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
ERFORDERLICHES PROFIL:
  • Academical degree in Engineering, Chemistry, Life Science, Pharmacy or equivalent (*****)
  • Profound experience in the pharmaceutical industry
  • Experience in equipment Qualification/Validation of synthetic molecules manufacturing and/or Quality Control (*****)
  • 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 (*****)
Nice to Have:
  • 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

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