Job description 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: - Solid knowledge of GMP regulations and standards - Excellent attention to detail - Ability to work in a fast-paced environment - 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 (Vapi)
🏢 Jay FineChem Private
📍 Vapi
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