• Partake in controlling, implementing, executing the activities of Quality Assurance.
• To carry out sample management.
• Verification of online rejection and destruction if any.
• Co-ordination and execution of validation and qualification activities.
• To check the compliance and execution of Standard Operating Procedures.
• To review the batch records and other related documents.
• Monitor compliance to systems & processes by frequent shop-floor rounds.
• Monitor compliance of the recipe and audit trail review of process equipments.
2. APQR (Annual Product Quality Review)
• Monitoring and execution of continued process verification (CPV) of critical process parameter (CPP).
• Review of Annual Product Quality Review and necessary corrective action.
3. Control sample management
• To carry out Control sample management.
• Destruction and Annual Product Review (Performing and checking) of control sample on monthly basis.
4. Certified Investigator
Jointly investigate the significant change, Out of Calibration (OOC), out of specification result (OOS), Out of trend (OOT) with the user department & review the recommended CAPA to ensure closure.
5. Audit Compliance and Walk through
Carry out Self-Inspection along with representative departments and tracking of compliance closure with
appropriate evidence.
6. People development
• Provide functional and technical guidance to the team through on the job coaching and support them in capability development
• Identify and recommend continuous improvement initiatives and adopt best practices.
• Keep self and team updated to developments and advances in his field of work