- Knowledge of Change Control, Corrective and Preventive Action,
- Knowledge of deviations, Training schedules and internal audits
- Vendor assessment
- Support Quality Risk Assessment and Root Cause Analysis investigations.
- Review and Approval of OOS and OOT investigations
- Support for preparation of Certificate of analysis
- Provide QA support during regulatory authority inspections, as applicable
- To prepare protocols and report for validation activities as and when necessary
- To support the management of quality systems, processes and procedures to assure product quality and safety
- To ensure compliance to internal and external regulations
- Preparation of working protocols for quality control department
- To issue and maintain quality related documents
- Knowledge of out of specification, OOT, OOC and LIR
- Able to prepare SOPs without supervision
- Maintain training records for laboratory
- Review of monthly calibration and daily calibration records
- Knowledge of chromatography advantageous
- Knowledge on use of BP, USP and ICH guidelines
- Previous QC experience is mandatory
Job Types: Full-time, Part-time
Work Location: In person
