and responsibilities of the proposed candidate(s): GMP Compliance:

- Monitor adherence to GMP standards across manufacturing, packaging, and storage processes.
- Perform routine audits and inspections to identify and resolve compliance gaps.
- Ensure that all equipment, materials, and processes comply with GMP and regulatory guidelines.

Documentation

- Review and approve batch records, SOPs (Standard Operating Procedures), and related quality documents.
- Maintain accurate and up-to-date records of GMP activities and compliance measures.
- Ensure timely completion of deviations, CAPAs (Corrective and Preventive Actions), and change controls.

Training & Awareness:

- Conduct GMP training sessions for employees at all levels.
- Develop and update training materials to reflect current regulations and company policies.
- Foster a culture of quality and compliance within the organization.

Regulatory Support

- Assist in preparation for regulatory inspections and customer audits.
- Coordinate with QA and regulatory teams to implement audit findings and corrective actions.




- Stay updated on changes in GMP regulations and implement necessary updates in the organization.

Process Improvement

- Identify opportunities to improve manufacturing processes while maintaining GMP compliance.
- Collaborate with cross-functional teams to streamline operations and enhance product quality.

Quality Monitoring

- Oversee environmental monitoring and ensure compliance with cleanroom standards.
- Ensure proper handling, storage, and labeling of raw materials, intermediates, and finished APIs.
- Investigate and resolve quality-related issues promptly.

Skills Required

- Strong knowledge of GMP regulations and standards
- Excellent attention to detail
- Ability to work in a fast-paced setting
- Strong problem-solving skills
- Effective communication and teamwork abilities.

Qualifications: M.Sc/B.Sc/ BE in Chemical.

Job Experience: Minimum 5-10 of experience in a GMP compliance role within the pharmaceutical industry, preferably in API/intermediates manufacturing.

📌 Gmp Coordinator (Bilimora)
🏢 Jay FineChem Private
📍 Bilimora