CQV Specialist (m/f/d)
- Involved in all validation activities including but not limited to: Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, among others
- Involved in the validation documentation including: URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ)
- Prepare validation documents
- Execution of IQ/OQ and PQ for equipment, systems and utilities
- Write reports of completed validation activities. Work to identify efficiencies in the validation program approach
- Work to apply lessons learned and stay informed of industry regulatory changes as it applies to equipment / facility validation
- Perform assigned Quality Systems activities including Document Management system, Change Control, Non-Conformities, and CAPA’s
- Write and/or revise procedures applicable to the Engineering activities
- Support the Engineering group to prepare the validation, requalification, and maintenance program
- Education: Bachelor’s degree in Engineering or technical field
- Good English language skills
- Prpfound experience in the Pharma industry as a CQV Engineer / Specialist
- Pleasant working atmosphere
- Further training opportunities
About the company