GMP Coordinator

Jay FineChem Private Limited; Vapi; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Jay FineChem Private Limited is seeking a GMP Compliance Specialist to oversee QA and regulatory alignment in manufacturing, packaging, and storage processes.

The role focuses on audits, deviation handling, CAPA, and training to maintain stringent GMP standards across the organization.

Qualifications

• Must have strong knowledge of GMP regulations and standards.
• Excellent attention to detail.
• Ability to work in a fast-paced environment.
• Strong problem-solving skills.
• Excellent communication and teamwork abilities.

Responsibilities

• Monitor GMP compliance across manufacturing, packaging, and storage processes.
• Perform routine audits and inspections to identify compliance gaps.
• Ensure that all equipment, materials, and processes comply with GMP and regulatory guidelines.
• Review and approve batch records, SOPs, and related quality documents.
• Maintain accurate and up-to-date records of GMP activities and compliance measures.
• Ensure timely completion of deviations, CAPAs, and change controls.
• 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.
• Assist in regulatory inspections and customer audits.
• Coordinate with QA and regulatory teams to implement audit findings.
• Stay updated on GMP regulation changes and implement updates.
• Identify opportunities to improve manufacturing processes while maintaining GMP compliance.
• Collaborate with cross-functional teams to streamline operations and enhance product quality.
• 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

GMP knowledge

Detail-oriented

Fast-paced environment

Problem-solving

Communication & teamwork

Education

M.Sc in Chemistry

B.Sc in Chemistry

BE in Chemical Engineering

Job description

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.
• 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 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.