QA Qualification manager

☞ Proclinical

View: 139

Update day: 24-04-2024

Location: Visp Valais VS

Category: Pharmaceutical / Chemical / Biotech

Industry:

Job type: Durée indeterminée

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Are you a QA Qualification Manager interested in working for one of the most interesting names in High-Tech Biopharmaceuticals?

Are you looking for something new?!

Title: QA Qualification Manager

Location: Visp, Switzerland

Rate: Open

Openings: 2 Manager

Contract/Perm: Contract (6-Months)

A Fantastic new role has just opened up at one of our leading Swiss based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.

Responsibilities:

  • Owns all quality related responsibilities for the commissioning and qualification (C&Q) activities of dedicated new facilities, equipment and utilities related to the GMP manufacturing of biologics & APIs.
  • Representative of Quality in the CAPEX project organization in regards to qualification of facilities, utilities, equipment and systems (incl. computerized systems).
  • Reviews and releases of qualification documents and SOPs.
  • Be a Subject Matter Expert (SME) and provides guidance and recommendations to internal or external customers.

Requirements:

  • Bachelor, Master degree or PhD in biotechnology, chemistry, life science or related field
  • Significant experience in the GMP regulated pharmaceutical industry; preferable in a role within a Quality Unit
  • Strong background in cGMP
  • Broad knowledge in qualification of equipment, facilities, utilities (biopharmaceuticals& APIs) and related Guidelines (e.g. ASTM, ISPE, GAMP)
  • Experience in interaction with all kind of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.)
  • Excellent verbal, written and interpersonal communications skills
  • Fluency in English, German would be an advantage

If you are interested, please do not hesitate to email or call me!

S.Hubert@Proclinical.com

DL: +44 203 949 8594

CH: +41 61 508 7073

Mob: +44 7592 053 700

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Deadline: 08-06-2024

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