07 Aug
|
Genora Pharma Sciences
|
India
07 Aug
Genora Pharma Sciences
India
GMP Compliance Executive – Manufacturing
Location: Pune, Maharashtra
Experience Required: 3+ Years
Industry: Pharmaceutical Manufacturing
About the Prospect
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.
Positive knowledge of GMP guidelines, documentation practices, CAPA, Change Control, Validation, and Qualification activities.
Solid 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.
Pay: From ₹350,000.00 per year
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
📌 Gmp Compliance Pune (India)
🏢 Genora Pharma Sciences
📍 India