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.
