Responsibilities:
1. Ensure documentation consistency across the CQ group and manage COMOS / KNEAT / DMS interfaces for CQ group.
2. Responsible for documentation management for the project CQV group, including creating templates, first-of-kinds, alignment across group, approval process, retention process, etc.
3. Coordination of Operational Qualification Protocol preparation and approvals, including release for OQ and PQ.
4. Coordination of GMP regulations and management of the training programme for Commissioning and Qualification activities.
5. Coordination and communication with other resources for Qualification / Documentation Management activities.
6. Self-manage CQ development review / approval activities with respect to COMOS/KNEAT platforms.
Qualifications:
1. Bachelor’s degree in Life Sciences or Engineering.
2. Solid experience in commissioning / qualification / validation (DQ, IQ, OQ, Commissioning) activities in the pharmaceutical/biotech industry.
3. Fluent English language written and verbal communication skills.
4. Experience with COMOS/KNEAT platforms.
5. CGMP knowledge and knowledge of regulatory requirements.
What We Offer:
1. Challenging and varied tasks in a promising and innovative industry.
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