GMP Coordinator

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 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.