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Quality Control Expert- Stability Testing

Eingestellt von Michael Bailey Associates - Zurich

Gesuchte Skills: Support

Projektbeschreibung

Quality Control expert - stability testing

We have a new opportunity for an experience laboratory experience to join a project which will focus on all GMP related QC activities for sterile products.

Daily tasks:
Analytical Change Control Management (QA Gate Approval, Change Phase Management)
Approval and Implementation of analytical TM (pharmaceutical dosage forms, excipients, packaging materials)
Approval of method validation (for cleaning validation)
Review/Approval of analytical change/transfer documents
Updating of SOPs/FRMs
Audit and inspection support
Ensure timely delivery of complete and consistent source data to DRA REG CMC
Coordinate and provide review of CMC documentation

Requirements:
University or academic degree in Chemistry, Biology, Pharmacy or equivalent
Advanced quality and regulatory understanding
Experience in the manufacturing of pharmaceutical drug products and Steriles/Biotechnology is an advantage
Good Analytical chemical and/or biological expertise
Profound knowledge in cGMPs
Pharmaceutical software applications, eg TEDI, CCex
Languages: English fluent and German at least conversational

Please send your CV

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

Projektdetails

  • Einsatzort:

    Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    12 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

  • Skills:

    support

Michael Bailey Associates - Zurich