25 Aug
|
Jay FineChem Private
|
Vapi
25 Aug
Jay FineChem Private
Vapi
and responsibilities of the proposed candidate(s):
nGMP Compliance:
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- Monitor adherence to GMP standards across manufacturing, packaging, and storage processes.
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- Perform routine audits and inspections to identify and resolve compliance gaps.
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- Ensure that all equipment, materials, and processes comply with GMP and regulatory guidelines.
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nDocumentation:
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- Review and approve batch records, SOPs (Standard Operating Procedures), and related quality documents.
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- Maintain accurate and up-to-date records of GMP activities and compliance measures.
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- Ensure timely completion of deviations, CAPAs (Corrective and Preventive Actions), and change controls.
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nTraining & Awareness:
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- Conduct GMP training sessions for employees at all levels.
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- Develop and update training materials to reflect current regulations and company policies.
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- Foster a culture of quality and compliance within the organization.
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nRegulatory Support:
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- Assist in preparation for regulatory inspections and customer audits.
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- Coordinate with QA and regulatory teams to implement audit findings and corrective actions.
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- Stay updated on changes in GMP regulations and implement necessary updates in the organization.
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nProcess Improvement:
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- Identify opportunities to improve manufacturing processes while maintaining GMP compliance.
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- Collaborate with cross-functional teams to streamline operations and enhance product quality.
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nQuality Monitoring:
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- Oversee environmental monitoring and ensure compliance with cleanroom standards.
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- Ensure proper handling, storage, and labeling of raw materials, intermediates, and finished APIs.
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- Investigate and resolve quality-related issues promptly.
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nSkills Required:
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- Solid knowledge of GMP regulations and standards
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- Excellent attention to detail
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- Ability to work in a fast-paced environment
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- Strong problem-solving skills
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- Effective communication and teamwork abilities.
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nQualifications: M.sc/B.sc/ BE in Chemical.
nJob Experience: Minimum 5-10 of experience in a GMP compliance role within the pharmaceutical industry, preferably in API/intermediates manufacturing.
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📌 GMP Coordinator (Vapi)
🏢 Jay FineChem Private
📍 Vapi