Manager Quality Assurance

JOB DESCRIPTION:

Primary Job Function & Core Job Responsibilities:
I.    Conduct audits of Raw and Packaging Materials vendors, including that of active material and excipient vendors for Abbott, EPD, India and other regions of EPD as per requirement.

II.    May also conduct audits of Third-Party manufacturers for finished products, Contract testing laboratories manufacturing / supplying products and services to Abbott, EPD, India.

III.    To plan and conduct internal audits for Abbott EPD India.

IV.    Review and periodic updating of Supplier management procedures in accordance with current corporate procedures and directives i.e. AQ, EQD, EID.
V.    Preparing audit schedules and verifying the accuracy, tracking adherence of audits as per annual audit schedule.

VI.    Participate in alternate vendor development projects.

VII.    To monitor all CAPA related to the audit findings are implemented appropriately as per defined timelines and also to upload and close in AudiQ system in Trackwise.

VIII.    Conduct due-diligence audits of potential new contract manufacturing sites.

IX.    Conduct “For Cause” audits to investigate quality issues and significant events.

X.    To ensure completion of Supplier performance monitoring on yearly basis.

XI.    To provide support to Inhouse Abbott facilities in EPD India audit readiness for Corporate and regulatory audits. 

XII.    To perform supplier risk assessments post Caution audit outcomes and high-risk outcomes based on annual performance monitoring.

XIII.    Ensure supplier complaints/Quality issues are addressed, support and coordinate for investigations with appropriate CAPAs in place.

XIV.    Collaborate with key stakeholders to facilitate business processes.

XV.    Review of QQ and Tech. pack documents for new vendors and alternate vendors.

XVI.    Support in preparation, updating and maintenance of Approved supplier lists.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

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