- 68 years of relevant experience in Pharmaceutical Quality Assurance, CMO Quality Management, or related Quality functions.
- Strong experience in reviewing deviations, CAPA, change controls, OOS/OOT, incidents and audit observations.
- Experience in CMO management and external manufacturing oversight.
- Good understanding of EU GMP and global/ROW GMP requirements.
- Experience in regulatory submission and post-approval variation support is preferred.
- Strong understanding of GMP, GDP, Quality Risk Management, CAPA, change management, deviation management and audit management.
- Experience working with MAHs, customers, CMOs, and cross-functional teams.
- Strong investigation review and root-cause analysis skills.
- Valuable written and verbal communication skills.
- Strong stakeholder management, negotiation, follow-up, and escalation skills.
- Ability to manage multiple CMOs, products, markets, and quality activities simultaneously.
- Strong documentation and analytical skills.
- Proficiency in MS Office and electronic QMS systems.
Preferred candidate profile
- Should be 4-8 yrs of expereince in CQA / OSD (Pharma)
- Education: M.Pharm/M.SC
- Location: Bommasandra, Bangalore