Exciting Opportunity for Quality Assurance Professionals! Brooks Steriscience Limited, a leading name in the pharmaceutical industry, is hiring for the position of Assistant Manager / Manager – Lab QA at their Karjan, Vadodara facility. If you have 10-12 years of experience in Lab QA and an M. Pharm degree, this could be your next career move!
Job Details: AM / Manager – Lab QA
- Company: Brooks Steriscience Limited
- Location: Karjan, Vadodara, Gujarat
- Position: Assistant Manager / Manager – Lab QA
- Department: Quality Assurance
- Qualification: M. Pharm
- Experience: 10-12 Years
- Email to Apply: bharti.makwana@brookssteriscience.com
About Brooks Steriscience Limited
Brooks Steriscience is a reputed pharmaceutical company known for its state-of-the-art manufacturing facilities and commitment to regulatory compliance. The company specializes in sterile and non-sterile pharmaceutical products, ensuring highest quality standards in line with global regulatory expectations (USFDA, WHO, EU-GMP).
Working at Brooks Steriscience means being part of a dynamic team that values innovation, quality excellence, and professional growth.
Key Responsibilities of AM / Manager – Lab QA
As a Lab QA Manager, your role will involve:
✔ Leading OOS (Out of Specification), OOT (Out of Trend), OOC (Out of Calibration), and deviation investigations in the lab.
✔ Reviewing and approving equipment calibration records, preventive maintenance schedules, and working standards.
✔ Overseeing stability studies, including sample charging and withdrawal as per regulatory requirements.
✔ Ensuring data integrity by validating and reviewing analytical data for commercial and stability batches.
✔ Reviewing and approving Analytical Method Validation (AMV) and Analytical Method Transfer (AMT) protocols/reports.
✔ Maintaining GLP (Good Laboratory Practices) and conducting training for QA personnel.
✔ Ensuring compliance with updated pharmacopeial standards (USP, EP, IP) and ICH guidelines.
✔ Preparing the lab for regulatory audits (USFDA, MHRA, WHO) and ensuring inspection readiness.
Desired Skills & Qualifications
- Education: M. Pharm (Pharmacy)
- Experience: 10-12 years in Pharmaceutical Quality Assurance (Lab QA)
- Strong knowledge of GMP, GLP, and regulatory compliance
- Expertise in OOS/OOT investigations, stability studies, and analytical method validation
- Familiarity with pharmacopeial standards (USP, EP, IP)
- Excellent documentation and audit management skills
How to Apply?
Interested candidates can email their updated resume with Current & Expected CTC to:
📧 Email: bharti.makwana@brookssteriscience.com
📍 Job Location:
Block No 61/62, Village Manglej, Nareshwar Road, Tal: Karjan, Dist: Vadodara, Gujarat – 391210
