Senior Executive Corporate QA

Role & responsibilities

• 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.
• Good 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