Senior Manager - Corporate Quality Audit

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.

JOB DESCRIPTION

• 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)