HR Manager at Jana care Med Tech Pvt Ltd
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Jana care - Quality Assurance Executive - Medical Devices (2-5 yrs)
Job Description :
- Support the creation, revision, and control of quality system documents needed to ensure product quality and adherence to applicable regulations.
- Assist in the planning and execution of the audit activities necessary for monitoring the Quality Management system and participate as a team member in all internal/external audits.
- Review and approve completed batch records and equipment logs for completeness and also ensure on-time calibration activities and preventive maintenance is completed. Escalate issues for appropriate handling.
- Track and support training activities to ensure on-time training completion for all employees, this includes new employee training, skill training, and change implementation training for new/revised documents.
- Support as required to track and report out the Quality metrics (CAPA, NCRs, Supplier monitoring etc) on a periodic basis for the site by working closely with various functional groups.
- Assists in completing the NCR (Non-Conformance Reporting), PPC (Product and Process Change) and Complaint Handling activities
- Responsible for batch release of the products prior to shipment to customers.
- Responsible for reviewing customer orders and approval of shipments from the Production facility
- Assist in the overall improvement of Production facility as per QMS.
Skills required :
Mandatory :
- Knowledge of ISO 9001 or 13485
- Good communication, verbal and written skills
- Analytical and problem-solving skills
Additional : Experience of handling internal and external audits
Qualification required : Bachelor's degree in Biomedical Engg or Biotechnology or Master's degree in Life Sciences / Biotechnology
Experience required : 2-4 years in Quality Assurance/Quality Control in Medical Devices Industry
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