Job Title:Manager - Corporate Quality AuditBusiness Unit:Global Quality & ComplianceJob GradeG11A / G10Location :MumbaiAt Sun Pharma, we commit to helping you “Create your own sunshine”- by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.Are You Ready to Create Your Own Sunshine?As you enter the Sun Pharma world, you'll find yourself becoming 'Better every day' through continuous progress. Exhibit self-drive as you 'Take charge' and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we 'Thrive together' and support each other's journeys.”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.
Key responsibilities:
To conduct six system-based Quality audits at all manufacturing locations of SUN sites as per requirements and corporate schedule including API manufacturing facilities. (Preferably previous experience of API Quality /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).
To perform trend analysis of audit observations.
Travel EstimateJob RequirementsEducational QualificationM.Sc / B.PharmExperienceTenure: 12 to 15 YrsYour Success Matters to UsAt Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together!Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).
