Posted:15 hours ago|
Platform:
On-site
Part Time
The Senior Executive – QA (Engineering Assurance) will be responsible for executing and reviewing qualification lifecycle documents for GMP equipment, utilities, and facilities. The role includes oversight of URS, DQ, IQ, OQ, and PQ protocols, engineering change controls, risk assessments (FMEA), and periodic requalification activities. This position works closely with Engineering, Validation, Projects, and cross-functional QA teams to ensure timely qualification and regulatory readiness. Key Responsibilities: QA review and approval of qualification protocols and reports (URS, DQ, IQ, OQ, PQ) Oversight on facility, utility, and equipment qualification activities QA support for engineering change controls and deviation handling Risk assessment and mitigation using tools like FMEA and HAZOP Periodic review and requalification planning Participation in internal/external audits and regulatory inspections Ensuring data integrity and documentation compliance across qualification records
Piramal Pharma Solutions
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