QA Manager Qualification

Thun  ‐ Vor Ort
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Beschreibung

QA MANAGER QUALIFICATION

Location: South of Switzerland, Thun area
Duration: until the end of the year
Start date: ASAP (latest 1st September)

In order to support the strategic growth investment of my client in the South of Switzerland, I am looking for an experienced quality leader, responsible for the equipment qualification.

Key responsibilities:
  • Owns all quality related responsibilities for the commissioning and qualification (C&Q)) activities of dedicated new equipment, facilities and utilities related to the GMP manufacturing of biologics & APIs.
  • Representative of Quality in the project organization in regards to qualification of facilities, utilities, equipment and 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


Key requirements:
  • Bachelor, Master degree or PhD in biotechnology, chemistry, life science or related field
  • More than 5 years of Experience in Biotech area
  • At least 5 years of Experience as QA Qualification/Validation position
  • Knowledge on USP / DSP and related Guidelines (e.g. ASTM, ISPE, GAMP)
  • First experience with the PQ phase (performance qualification)
  • Strong background in cGMP
  • Experience in interaction with all kind of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.) beneficial
  • Excellent verbal, written and interpersonal communications skills
  • Fluency in English, German and French would be an advantage


Keywords: QA Manager Qualification, equipment qualification, commissioning, C&Q, facilities, utilities, GMP, manufacturing, documents, SME, biotechnology, chemistry, life science, Pharmaceuticals, Biotech, QA, USP, DSP, Guidelines, cGMP, Schweiz, Switzerland, Thun

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.
Start
07/2022
Von
Real Staffing
Eingestellt
13.07.2022
Projekt-ID:
2424661
Vertragsart
Freiberuflich
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