Executive / Senior Executive – GMP Compliance (Biotechnology Manufacturing)
Location: Ghotawade, Pune, Maharashtra
Education: Post Graduate in Biotechnology (M.Sc. Biotechnology / PG Biotechnology)
Experience: 3–6 Years
Job Type: Full-Time
About the Opportunity
Are you passionate about ensuring quality and compliance in biotechnology manufacturing?
We are hiring an Executive / Senior Executive – GMP Compliance to join a fast-paced, innovation-driven biotechnology manufacturing environment. This role offers the opportunity to work on GMP compliance, quality systems, validation activities, regulatory readiness, and manufacturing excellence while collaborating with cross-functional teams.
If you have hands-on experience in GMP documentation, validation, investigations, and quality management systems, we'd love to hear from you.
Key Responsibilities
- Ensure GMP compliance across biotechnology manufacturing operations.
- Prepare, review, and approve GMP documents, SOPs, protocols, reports, and Batch Manufacturing Records (BMRs).
- Manage manufacturing documentation and ensure compliance with quality standards.
- Handle Quality Management System (QMS) activities including Change Control, Deviations, CAPA, Investigations, and Risk Assessments.
- Participate in equipment qualification (IQ, OQ, PQ), process validation, and cleaning validation activities.
- Coordinate technology transfer documentation with QA, QC, R&D, Engineering, and Regulatory Affairs teams.
- Support internal, customer, and regulatory audits by ensuring facility readiness and documentation compliance.
- Conduct investigations, perform Root Cause Analysis (RCA), and implement effective Corrective and Preventive Actions (CAPA).
- Drive contamination control strategies and Right First Time (RFT) initiatives across biotechnology manufacturing.
- Coordinate departmental GMP training programs and promote a strong culture of quality and compliance.
- Maintain document control and electronic documentation in accordance with GMP requirements.
Required Qualifications
- Post Graduate in Biotechnology (M.Sc. Biotechnology / PG Biotechnology).
- 3–6 years of experience in GMP Compliance within the biotechnology manufacturing industry.
- Strong understanding of GMP guidelines, documentation practices, and manufacturing compliance.
- Experience with QMS activities such as CAPA, Change Control, Deviations, Risk Assessment, and Investigations.
- Hands-on exposure to equipment qualification (IQ/OQ/PQ), process validation, and cleaning validation.
- Excellent documentation, communication, and coordination skills.
- Ability to work effectively with Manufacturing, QA, QC, Engineering, Warehouse, and R&D teams.
Preferred Skills
- GMP Compliance
- Biotechnology Manufacturing
- SOP Preparation & Review
- Batch Manufacturing Records (BMR)
- Validation & Qualification (IQ/OQ/PQ)
- Cleaning Validation
- Process Validation
- CAPA & Deviations
- Change Control
- Risk Assessment
- Root Cause Analysis (RCA)
- Regulatory Audit Readiness
- Documentation Management
- Quality Management Systems (QMS)
Why Join Us?
- Work in a modern biotechnology manufacturing environment.
- Be part of a quality-driven and compliance-focused culture.
- Gain exposure to regulatory audits, validation projects, and manufacturing excellence initiatives.
- Collaborate with experienced professionals in a high-performance team.
- Excellent opportunities for learning, ownership, and career growth.
Apply Now
If you're ready to take the next step in your biotechnology career, we'd love to connect with you.
Contact: +91 8426997769
Only shortlisted candidates will be contacted.
Pay: From ₹500,000.00 per year
Application Question(s):
- Total Experience?
- GMP Experience?
- Biotech Experience?
- CAPA Experience?
- Current Location?
- Relocate to Pune?
Education:
Experience:
- Manufacturing: 3 years (Required)
Work Location: In person
