Key Responsibilities
Execute CQV activities for GMP-regulated pharmaceutical and biopharmaceutical facilities.
Prepare and review validation documents, including plans, IQ/OQ/PQ protocols, test scripts, and reports.
Support validation of equipment, utilities, facilities, and computerized systems in compliance with GMP, GAMP 5, and 21 CFR Part 11.
Coordinate with Engineering, QA, clients, and vendors on validation activities.
Conduct risk/impact assessments, deviation investigations, and CAPA.
Support FAT, SAT, commissioning, and qualification of new equipment and systems.
Maintain accurate validation records and data integrity.
Requirements
Bachelor’s Degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related field.
3–5 years of CQV/validation experience in pharmaceutical or biopharmaceutical industries.
Strong documentation, analytical, problem-solving, and communication skills.
Experience with equipment, utilities, cleanrooms, HVAC, water systems, or CSV is preferred.
Knowledge of FDA 21 CFR Part 11, EU GMP, GMP, GAMP 5, and data integrity.
For interested applicant, kindly send your resume in Word/PDF format, include the following informations:
1. Current Salary
2. Expected Salary
3. Availability
4. Reason for leaving
Thank you for your application and we regret that only shortlisted applicants will be notified
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