Senior Manager - Corporate Quality Audit

18 - 20 years

0 Lacs

Posted:6 days ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Position :

Sr. Manager – 1

Grade

: G9

Job Location

: Sun house, Mumbai

Education

: B. Pharm / M. Pharm Graduate

Experience :

18-20 Years

Job Summary:

  • This role is part of Corporate Quality Audits function responsible for conducting Sun site audits.
  • The role is responsible to asses/audit Sun manufacturing sites against current regulatory expectations / standards to ensure regulatory compliance. It includes adhering to applicable regulations, as well as Sun Pharma's policies and procedures.
  • To conduct six system-based Quality audits at all manufacturing locations of SUN sites as per requirements and corporate schedule including sterile manufacturing facilities. (Should have previous experience of Sterile operations or audits)
  • To prepare audit report, review of response received from sites within timeline.
  • To ensure that audit findings are based on facts and with respect to regulatory requirements.
  • In case as a lead auditor, coordination with audit team and auditee, compilation of audit findings and review of audit report
  • To appropriately categorize non-conformity into Critical, Major and Minor categories.
  • To assist business areas in achieving compliance to regulations, and Sun polices / procedure including sterile manufacturing compliance.
  • To review & verify response submitted by site based on supporting evidences.
  • To ensure audit closure after receipt and review of satisfactory compliance.
  • To re-audit and conduct adhoc audit of the site, as and when required.
  • To support Sun sites in pre- audit preparation and reviews (whenever required)

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