GMP Coordinator ( API Pharma sector only )

The GMP (Good Manufacturing Practice) Coordinator will be responsible for ensuring compliance with GMP regulations and standards within the manufacturing facility. This includes monitoring processes, providing training, and ensuring that all activities meet regulatory requirements. The GMP Coordinator plays a critical role in maintaining the quality and integrity of API and intermediates manufacturing.

Job Location: Vapi, Gujarat

Reporting To: Production Manager/Head

Key Responsibilities:

1. GMP Compliance

• Monitor and ensure adherence to GMP standards across manufacturing, packaging, storage, and related operations.
• Conduct routine GMP audits and inspections to identify compliance gaps and ensure timely corrective actions.
• Ensure equipment, raw materials, processes, and facilities comply with applicable GMP and regulatory requirements.
• Monitor implementation and effectiveness of GMP procedures across the organization.

2. Documentation & Quality Systems

• Review and approve Batch Manufacturing Records (BMRs), SOPs, protocols, and other quality-related documents.
• Ensure accurate, complete, and timely maintenance of GMP documentation and records.
• Review and monitor deviations, CAPAs, change controls, and investigation reports.
• Ensure compliance with good documentation practices and data integrity requirements.

3. Training & GMP Awareness

• Conduct GMP and quality awareness training for employees across departments.
• Develop and periodically update training materials based on regulatory requirements and internal procedures.
• Promote a strong quality, GMP, and compliance culture within the organization.

4. Regulatory & Audit Support

• Support preparation and coordination for regulatory inspections, customer audits, and internal audits.
• Coordinate with QA, Regulatory Affairs, Production, QC, and other functions for closure of audit observations and corrective actions.
• Stay updated on changes in GMP regulations, guidelines, and industry best practices and support their implementation.

5. Process & Quality Improvement

• Identify opportunities to improve processes while ensuring continued GMP and regulatory compliance.
• Work closely with cross-functional teams to improve operational efficiency, documentation practices, and product quality.
• Support implementation of continuous improvement and quality enhancement initiatives.

6. Quality & Environmental Monitoring

• Oversee environmental monitoring activities and ensure compliance with applicable cleanroom standards.
• Ensure proper handling, storage, labeling, and status identification of raw materials, intermediates, and finished APIs.
• Monitor quality-related issues and support timely investigation, root-cause analysis, and corrective actions.

Skills Required:

• Strong knowledge of GMP regulations, pharmaceutical quality systems, and regulatory requirements.
• Experience in GMP documentation, audits, deviations, CAPA, change control, and investigations.
• Excellent attention to detail and strong analytical/problem-solving skills.
• Good communication, coordination, and teamwork abilities.
• Ability to work effectively in a fast-paced pharmaceutical manufacturing environment.
• Strong understanding of compliance requirements in API/intermediate manufacturing.

Qualification:

• M.Sc. / B.Sc. / B.E. in Chemical Engineering or related discipline.
• Experience
• 510 years of relevant experience in GMP Compliance, Quality Assurance, or a related quality function within the pharmaceutical industry, preferably in API/intermediates manufacturing.