Quality Assurance
2 months ago
Preparation of documents of QA and authorizing documents of other departments for regulatory compliance.
- Preparation, review of quality manual, validation master plan.
- Review of filled records of process and QC.
- Co-ordination of activities related to Process department and quality control in connection with maintenance of overall quality of the products
- Monitoring and control of established quality management systems and its documentation.
- To organize and impart GMP training.
- Organizing and coordinating in internal audit.
- Organization of Validation activities and review and approval of their report
- Coordinates in handling deviations, Change control, CAPA and its resolution and follow up.
- Coordinates in handling nonconforming/rejected products and its resolution
- Coordinating in complains and product recall activities resolution.
- To Organize to Carry out assessment of Suppliers and approving them.
- To prepare COA of Final Product Release.
- In-Process Inspection and Final Testing as per testing procedure.
- Final Inspection as per plan and Maintain non-conformance records for any discrepancy found.
- Quality of products to be maintained without any rejection(s).
- Analysis of data for In-Process and Final Inspection.
- Identification Traceability of all finished products.
- Test Certificates, Manuals etc., to be sent to customers along with dispatch of the products.
- Control of Monitoring and Measuring Devices
- Maintaining records of Monitoring and Measuring devices and get it calibrated from time to time.
- Identification Traceability of the devices to be maintained.
- Carry out any other job-related activities as and when deemed necessary.
- Review of Computer software validation documents.
- A good working knowledge of ISO 9001 or IATF 16949 requirements is an added advantage Understanding of PPAP is a an added advantage
- Any other work assign by head of the department.
**Experience**:
- total work: 2 years (required)
- pharmaceutical manufacturing facility.: 2 years (required)
Work Location: In person
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