Asst Manager - Quality Control

Responsible for inspection of raw material, packing material, in-process and finished products
 Responsible for review, verification and approval of QC results and Certificate of Analysis (COA)
 Responsible for reviewing production batch records as per GDP
 Maintain all inspection results and batch release in SAP
 Ensure compliance to GMP & GLP to assure consistent quality during entire product realization process
 Prepare, review & approve relevant SOPs/WIs/Protocols/Reports/Records/Checklists
 Prepare monthly MIS for analysis
2. Statutory & Regulatory Compliance
 Ensure compliance to Medical Device Regulation (MDR 2017 & amendments) and CDSCO guidelines as
applicable to IVD reagent manufacturing
 Ensure compliance to applicable ISO standards
 Support external, internal and corporate audits
 Lead change control, deviations, non-conformances, CAPA and complaint investigations
 Comply with safety and environmental requirements
3. Validation/Stability
 Prepare, execute & review validation/verification/stability protocols and reports
 Support transfer activities of new reagents/products
 Support development of alternate vendors for new packaging / raw materials
4. Equipment Management
 Responsible for qualification (IQ/OQ/PQ) of all instruments & equipment
 Ensure calibration & maintenance of all instruments & equipment
5. Training & continuous improvement
 Responsible for training subordinates to develop competency
 Drive process improvements (Kaizen Activities)