GMP Compliance Executive – Manufacturing
Location: Pune, Maharashtra
Experience Required: 3+ Years
Industry: Pharmaceutical Manufacturing
About the Opportunity
We are hiring for India's Leading Pharmaceutical Company. We are looking for experienced professionals who are currently working in GMP Compliance within a pharmaceutical manufacturing facility.
Key Responsibilities
- Ensure compliance with Good Manufacturing Practices (GMP) in the manufacturing department.
- Prepare, review, and maintain GMP documents, SOPs, Batch Manufacturing Records (BMR), and Master Formula Records (MFR).
- Handle Change Controls, Deviations, CAPA, and other Quality Management System (QMS) activities.
- Prepare and review Cleaning Validation, Process Validation, and Product Changeover protocols.
- Participate in equipment qualification and validation activities (IQ, OQ, PQ, PV).
- Conduct risk assessments related to manufacturing processes, equipment, facilities, and personnel.
- Coordinate with QA, QC, R&D, Regulatory Affairs, and Manufacturing teams to ensure compliance.
- Support internal and external GMP audits and ensure audit readiness.
- Maintain training records and compliance documentation as per regulatory requirements.
Required Qualifications
- M.Sc. in Biotechnology, Microbiology, Life Sciences, Pharmacy, or a related discipline.
- Minimum 3 years of relevant experience in GMP Compliance within a pharmaceutical manufacturing company.
- Good knowledge of GMP guidelines, documentation practices, CAPA, Change Control, Validation, and Qualification activities.
- Strong documentation, communication, and problem-solving skills.
Preferred Candidate
- Currently working in a GMP Compliance role in the manufacturing department.
- Experience in handling manufacturing compliance documentation and audit activities.
- Immediate joiners or candidates with a short notice period are preferred.
Application Question(s):
- Are you currently working in GMP Compliance in a pharmaceutical manufacturing company? ( yes/ No)
- Do you have experience handling Change Control, Deviations, and CAPA? ( Yes/ No)
- What is your highest qualification?
What is your Highest Qualification - M.Sc. Biotechnology( ( Yes/No)
Work Location: In person
