Technical Quality Assurance Manager ROCGJP00028872

Vor 2 Tagen


Basel, Schweiz Coopers Group GmbH Vollzeit

Contract duration: 1 year

Extension: very likely

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

Requirements:

  • Academical degree in Engineering, Chemistry, Life Science, Pharmacy or equivalent
  • Fluent German and English are mandatory for this position
  • 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
  • Successful performance in health authority inspections and internal GMP audits
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