Duration: Until //5. Possible extension
Location: Valais
The scope of activities includes the coordination on the installation of equipment, drafting the IQ/OQ/PQ protocols, execution of the IQ/OQ/PQ and documenting the results according cGMP requirements.
Responsibilities:
1. Validation activities including but not limited to: Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, among others.
2. URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ).
3. Prepare validation documents. Execution of IQ/OQ and PQ for equipment, systems and utilities.
4. Write reports of completed validation activities. Work to identify efficiencies in the validation program approach.
5. Work to apply lessons learned and stay informed of industry regulatory changes as it applies to equipment / facility validation.
6. Perform assigned Quality Systems activities including Document Management system, Change Control, Non-Conformities, and CAPA’s. Writing and/or revising procedures applicable to the Engineering activities.
7. Support the Engineering group to prepare the validation, requalification, and maintenance program.
8. Perform other duties as assigned.
Requirements:
9. Bachelor’s Degree in Science or Technical field
10. 3-5 years of experience in pharma Industry