Qms Executive

Healthium Medtech

5 - 7 years

3 Lacs

sri city

Posted:1 week ago| Platform:

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Skills Required

quality management system audit documentation iso audit iso documentation qms implementation customer audits regulatory audits mrm reports raising capa

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Comply of QMS in-line with USFDA 21 CFR part 820, CE (EUMDR), ISO 9001:2015, ISO 13485:2016, EN ISO 13485:2016 for Sri City plant).
To review and update the Quality Management System as and when required.
To promote awareness of regulatory and customer requirements throughout the plant through continuous interaction and ensure that Quality Management System addressing such requirements are followed.
Ready for announced and unannounced audits at any time.
Ensure QMS documents are updated and kept ready for ongoing customer audit & regulatory audit.
Assist QA Manager in collecting documents and preparing MRM reports, MOM and follow-up of actions agreed upon.
Ensure that all the cross-functional team are prepared and ready for the ongoing audits with all the relevant updated documents.
To issue and control the QMS & QSP and to maintain master copies of QMS, QSP.
Control of all department SOPs, formats and records, preparation, approval and issuance.
To maintain obsolete copies of document for reference, if necessary.
Planning and conducting IQA and follow-ups for NCs making summaries for the final report.
To maintain records pertaining to the Quality Management System as detailed in the procedure for control of records.
Follow up, collecting and preparing quality objective reports as per the defined frequency.
Closing NCR report by verifying the action.
Raising CAPAs for the non-conformance and closing by providing appropriate justification for internal and external observations.
Plan and conduct vendor audits.
Preparation of trend analysis reports annually.
Perform batch reconciliation of batch manufacturing records for finished product batch release.

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