GMP Coordinator

6 days ago

valsad district, India Jay FineChem Private Limited Full time

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.

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