CQ Documentation Preparation Lead 100% (m/f/d)

Ihre Aufgaben:
• Ensure documentation consistency across the CQ group and manage COMOS / KNEAT / DMS interfaces for CQ group

• Responsible for documentation management for the project CQV group. Creating templates, first-of-kinds, alignment across group, approval process, retention process, etc.

• Coordination of Operational Qualification Protocol preparation and approvals, including release for OQ and PQ

• Coordination of GMP regulations and management of the training programme for Commissioning and Qualification activities

• Coordination and communication with other resources for Qualification / Documentation Management activities

• Self-manage CQ development review / approval activities with respect to COMOS/KNEAT platforms

Ihre Qualifikationen:
• Bachelor’s degree in Life Sciences or Engineering

• Solid experience in commissioning / qualification / validation (DQ, IQ, OQ, Commissioning) activities in the pharmaceutical/biotech industry
• Fluent English language written and verbal communication skills

• Experience with COMOS/KNEAT platforms

• CGMP knowledge and knowledge of regulatory requirements

Ihre Vorteile:
• Challenging and varied tasks in a promising and innovative industry

Projektdauer: 12 MM


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