CMO Quality Audit Lead

Job Title
CMO Audit Lead

Business Unit
Global Quality & Compliance

Job Grade
G7 (General Manager)

Location :
Mumbai

At 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
To plan and execute quality audits of Global CMO, CWH/CNF, Aseptic consumable suppliers as per the audit program (Routine, Qualification & For Cause audits) to ensure maintenance of Quality Standards in compliance to cGMP and regulatory requirements .

Key Responsibilities

• To prepare and approve the audit schedule of CMO's, CWH & CNF's, Aseptic consumable suppliers.
• To plan, co-ordinate with commercial department to conduct audits as per schedule.
• To prepare Planner, Schedule, Audit Report, including non-compliances and review compliance reports thereof to close the audit. This includes performing routine follow up of performed audits to ensure timely compliance and closure of the audit.
• To assign the audits based on the expertise and evaluation of auditor.
• To participate in the audits and to identify non-conformance with respect to Quality / Systems / Procedures / Operations against the regulatory requirements.
• To execute on-site / virtual / desk audits and review of quality management systems established in all the six systems, as applicable.
• To review and approve the audit reports and ensure corrections, if any.
• To provide the final audit report to the Commercial Department within 30 calendar days.
• To review and verify the audit responses received from the sites and ensure closure of audit.
• To prepare monthly report and to highlight key areas of concern in the monthly report.
• To participate in the product release sites / Qualified Person sites audits to ensure that the product is being released as per the regulatory requirement.
• To communicate the outcome of audit, based on the risk associated with the patient, regulatory compliance and business risk, to facilitate making decision of Approval / Di-approval.
• To ensure training of auditors to update on current / upcoming regulations.
• To follow Corporate Quality Policies / Global Quality Standards and applicable regulatory guidelines.
• To execute Global due-diligence, For cause and QMS audits as per the requirement.
• Participate & execute the project work assigned by reporting authority.
• To control and monitor the budget / expenses of the team.
• Periodic monitoring of annual KPI's of team.
• All other duties as assigned by Head Corporate Quality Compliance and CQA.

Travel Estimate
Job Requirements
Educational Qualification
M.Sc (Microbiology)

Experience
Tenure:
QC / QA Professional in Microbiology & Quality Assurance with 20 to 22 years of experience in microbiological sciences, cGMP/GLP, pharmaceutical product test methods development and validation; Document / Process gap assessment, Quality Assurance and Regulatory as well as Pharmacopeia Compliance.

Processes Known: Aseptic Processing, Terminal Sterilization, BFS Technology, Lyophilization, Prefilled Syringes, Oral Solid Dosages, Oral Liquids, Oral Powders & API.

Certified by Indian FDA for microbiological and sterility testing.

Maintenance of cGMP; Developing, updating and reviewing Quality Systems; Root Cause Investigations, Implementation of CAPA activities; OOS/Deviation Management; Compliant Handling, Aseptic Process Simulation and Process Optimization.

Your Success Matters to Us
At 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).