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:
• Strong knowledge of GMP regulations and standards
• Excellent attention to detail
• Ability to work in a quick-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
Reply to this offer
Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.