Interim QA Specialist (m/f)
Immediate availability required
Global pharmaceutical organization
About Our Client
Our client is a leading pharmaceutical company with their European headquarter in Switzerland.
Your responsibilities include but are no limited to:
- QA oversight for Qualification and validation, Adaptation and implementation of procedures, Continuous improvement, Engineering and automation
- Reviewing GMP documents and raw data for compliance to applicable regulatory and
corporate guidance documents, such as CAPA´s, deviations, operational procedures,
- Review/approval of change control documents and activities associated with change control implementation.
- Keep up to date on cGMPs and regulatory requirement s as well as global procedures, guidelines and policies.
- Proactively identify and propose resolution to both technical and compliance issues/gaps, as well as development and implementation of Quality Systems.
- Responsible for GMP assessment on quality engineering documents
The Successful Applicant
- Bachelors/Master's degree in Engineering, Life Sciences or another closely related discipline.
- 4+ years of experience in the validation of laboratory, production equipment and knowledge of production methodology involved in biopharmaceutical drug substance production.
- Experience in collaborating with colleauges at every level of the organization and from multiple functions, including engineers, Manufacturing personnel, SME's on equipment and knowledge of biotechnology API production.
- Self-driven and take ownership and responsibility for own assignments.
- Good communication skills in English and preferably German.
What's on Offer
Be part of a growing international pharmaceutical organization.