QA Process Validation

Role & responsibilities

We are looking for an experienced QA Validation professional with 78 years of experience in a pharmaceutical manufacturing environment, preferably with exposure to a sterile regulated facility. The role will be responsible for planning, executing, reviewing, and maintaining Process Validation, Cleaning Validation, and Equipment Qualification (DQ/IQ/OQ/PQ) activities.

The candidate will coordinate with Production, QA, QC, Engineering, and Warehouse teams to ensure timely completion of validation activities and maintain compliance with cGMP, WHO-GMP, EU-GMP, USFDA, and PIC/S requirements. The role also involves validation documentation, risk assessments, change control, deviation/CAPA, data integrity (ALCOA+), and Good Documentation Practices.

Qualification: B.Pharm/M.Pharm or M.Sc. in Chemistry, Pharmaceutical Chemistry, Biotechnology, or equivalent.
Experience: 7-10 years in QA Validation within pharmaceutical manufacturing, preferably sterile operations.

Preferred candidate profile