Quality Assurance Reviewer

10 - 12 years

10 - 12 Lacs

Posted:11 hours ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Job Title

Job Location

Department

Reports to

Job Objective

To perform the QA activities in view of system upgradation and improvement in the existing procedures.

Job Role:

1. Execution & co-ordination for investigations, Identification of root cause along with assignment of adequate CAPAs for Returned material, Incidents, Deviation, OOS, OOT, complaints & other quality events.

2. Logging, Review & Closing of the change controls and CAPAs along with implementation of CAPA and its effectiveness verification as applicable.

3. Responsible as site representative during Regulatory Audits and customer inspections to co-ordinate with the Inspectors /Auditors.

4. Preparation & review of quality risk assessment reports of products & general systems

5. Conduct on the Job Training and cGMP trainings.

6. Implement documentation system to develop, maintain, distribute and control of all Quality Control, Quality Assurance, Production, Maintenance and Warehouse records.

7. Planning & execution of internal quality audits and perform vendor audits for the KSMs and packaging materials for vendor qualification.

8. Co-ordination with the customer for compliance and day to day issues.

9. Quality agreements review and preparation.

Job Qualification:

Job Experience:

Desired attributes:

  • Technical / Functional:

  • Should have exhaustive knowledge on the drafting skills (E.g. Investigations, Responses & compliance).
  • Should have sound command on the English with speaking and Writing.
  • Sound knowledge of the production operations, QC analytical techniques & facility and maintenance functions.
  • Behavioral:

Team management, Leadership, Project management, Proactive, Time management and Critical thinker.

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