Senior Officer

Key Responsibilities

• Validation: Manage process, cleaning, and hold time protocols and maintain related reports
• Review: Audit BPCR, BPR, PCOCR, and SOPs to ensure compliance with regulatory and internal standards
• Utilities: Qualify and monitor HVAC, water, nitrogen, and air systems for operational readiness
• Quality Assurance: Execute Annual Product Quality Review (APQR), QMS activities, and stability monitoring
• Shop Floor Oversight: Conduct plant rounds to ensure proper implementation of validation protocols and adherence to processes
• Prepare and maintain documentation for audits, inspections, and regulatory submissions
• Collaborate with cross-functional teams to resolve deviations and implement corrective actions