Posted on Jan 8, 2021 by Stamford Consultants AG
- Owns all quality related responsibilities for the commissioning and qualification activities of dedicated facilities, equipment, utilities and systems related to the GMP manufacturing of biologics.
- Representative of QA Qualification in the project organization in regards to qualification/validation of facilities, utilities, equipment and systems (incl. computerized systems)
- Support the transfer from the project into production phase and support the handover of the facility to Operation/QA Operation
- Reviews and releases Qualification Documents (URS, Qualification Plan & Report, DQ/IQ/OQ/PQ Reports, etc.)
- Representative of QA Qualification during FATs
- Performs assessments and approvals of technical changes requests
- Supports and approves quality risk analysis
- Review & approve deviations reports
- Bachelor, Master degree or PhD in biotechnology, chemistry, life science or related field
- 5+ years of experience in the GMP regulated pharma industry within Quality Unit
- 3+ years of experience related to Commissioning and Qualification (C&Q) of facilities, utilities, equipment and systems
- Good understanding of cGMP regulations and Guidelines
- Good understanding of (cGEP)
- Strong problem-solving skill and attention to quality is a must
- English & German fluency
Aerotek, an Allegis Group company. Allegis Group AG, Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek is a company within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available.
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