An established Indian pharmaceutical company with a strong legacy and a diverse formulations portfolio, also operating as a CDMO for domestic and global markets, with an expanding presence across Asia and the GCC.

1. Ensure compliance with current GMP requirements and applicable regulatory guidelines.
2. Support and manage Quality Assurance, Quality Control, Regulatory Affairs, and compliance activities.
3. Lead preparation and coordination for regulatory inspections and customer audits.
4. Manage deviations, CAPA, change controls, complaints, investigations, and quality risk management activities.
5. Ensure implementation and maintenance of robust Quality Management Systems (QMS).
6. Review and approve quality documents, SOPs, validation protocols, and reports.
7. Drive continuous improvement initiatives to enhance quality systems and regulatory compliance.
8. Coordinate with Manufacturing, Engineering, Supply Chain, and R&D teams to ensure quality objectives are achieved.
9. Monitor quality metrics and compliance trends and recommend corrective actions where necessary.

● 8 to 10 years of experience in Pharmaceutical Quality Assurance, Quality Compliance, or Regulatory Affairs.

● Experience with MHRA-approved pharmaceutical manufacturing facilities in India is mandatory.

● Candidate should have faced and actively participated in at least 4 MHRA inspections/audits.

● Exposure to 3 or more US FDA inspections/audits will be preferred.

● Strong knowledge of EU GMP, MHRA requirements, Data Integrity, CAPA, Change Control, Validation, and Quality Risk Management.

An opportunity to lead quality compliance and regulatory strategy across MHRA, US FDA, and EU GMP frameworks, managing QA/QC operations, driving audit readiness, and ensuring regulatory excellence for a pharmaceutical formulations manufacturer with international certifications and exports to regulated markets.