Found Description
Position Overview
PQE Group is seeking an experienced Commissioning, Qualification & Validation (CQV) Consultant in Granada. The role focuses on the qualification and validation of equipment and systems in biotechnological production facilities.
Responsibilities
- Execute commissioning, qualification, and validation activities for pharmaceutical/biotech equipment and systems.
- Prepare, review, and execute C&Q; and validation documentation (URS, DQ, IQ, OQ, PQ protocols, test scripts, and summary reports).
- Collaborate with cross‑functional teams (Engineering, QA, Validation, Manufacturing) to ensure compliance with GMP, regulatory guidelines, and project timelines.
- Review technical documentation, P&IDs, FAT/SAT protocols, and vendor manuals.
- Identify, troubleshoot, and document deviations, ensuring timely resolution.
- Ensure all activities meet GMP, FDA, EMA, and ICH requirements.
- Provide project updat...