Location: South of Switzerland, Thun area

Duration: until the end of the year

Start date: ASAP (latest 1 st 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.