Technical QA Manager

vor 18 Stunden

Basel, Schweiz Flexsis 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.


Responsibilities:
  • 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.

Minimum Requirements:
  • 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 of 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-confidence to take over new responsibilities and tasks.
  • Ability to speak up, listen to other opinions, and rethink one's own way to ensure a highest level of success.
  • Knowledge of Pharmaceutical Development and about the special needs and roadblocks regarding GMP-compliant production.

Application Process:

Interested? You can find more information here: Infopackage. Please apply via the "Bewerben" button below and answer all questions, otherwise we will be unable to process your application. Please upload your CV in English or German only, along with your degree certificate and latest reference letter.

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