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)