:
1. Responsible for Overall QA activities & to look after QMS compliance in accordance with ISO 13485/cGMP.
2. Preparation & Up-gradation of SOP, Specifications
3. Maintain the Records of BMR, BPR, Batch Inspection Documents
4. Maintaining Document & Record Control
5. Preparation & Up-gradation of Routine Validation Protocol & Reports.
6. Handling CAPA, Non- Conformance & Deviations
7. Require understanding on QA & Regulatory activities in medical device industry
8. oversee the risk management process and related activities.QA for MDR (MEDICAL DEVICE RULES) / ISO13485
COMPULSORY
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