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QA Associate

vor 3 Monaten

BaselStadt, Schweiz CK Group Vollzeit
Job Title: QA Associate

Work Location: Basel

Country: Switzerland

Duration: 6 months

Rate: CHF 35.13 CHF 44.87 (8 hours per day) depending on experience

Your main duties as a QA Associate will include:
  • Supporting the timely release of GMP relevant documents and batches and support adherence to compliance with cGMP in TRD.
  • Receiving incoming documents, including executed batch records, work orders, vendor labels, packaging instructions.
  • Performing documentation needed for the batch record review, including Analysis Reports, Specifications for clinical development, and country label approval.

Additional duties will include:
  • Writing and reviewing procedures and forms related to the QA Batch record Review Process.
  • Contributing to Right First Time performance reports for release of IMPs.
  • Supporting and collaborating with QA & GCS Line Unit in process improvements, Quality & Compliance issues and in the use of GMP relevant IT tools and processes.
  • Supporting the use, improvement, evaluation and implementation of GMP relevant IT tools and processes.

Your Background:
  • Technician (10 years experience) or Bachelor (5 years experience).
  • Fluent in site language German, as well as English required (adequate knowledge oral & written).
  • Communication skills to sufficiently address GMP and logistic related questions with line unit experts.
  • Scientific, technical and regulatory knowledge in a specific area. Basic knowledge of drug development.
  • Detailed knowledge of cGMP, working knowledge of safety and environmental regulations and guidelines.

Apply

It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference 106738 in all correspondence.