Title:  Manager Corporate Quality Audit

Title:

Manager Corporate Quality Audit

Business Unit:

Corporate Quality Audit

Job Grade

Manager / G11/G10

Location:

Mumbai, Sun House

Key Responsibilities

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 DESCRIPTION:

Job Summary:   

• To ensure that SUN Pharma Quality and Compliance Standards, and applicable global regulatory authorities’ requirements are met and that all SUN affiliates, Third parties, Suppliers and SUN sites / Operational Units to achieve, maintain and improve the adequate level of compliance, through “independent auditing and follow-up”.

Essential Job Functions:   

• To conduct thorough GMP Audit of Contract Manufacturing Organization (CMO) sites involved in manufacturing of different dosage forms including Biologics to ensure that they always deliver high quality and standard products and remain compliant with GMP requirements.

• To conduct GMP audits of RM & PM Vendors (Manufacturer).

• To co-ordinate with CMO sites / Vendor for desired documents for pre-audit preparation, logistics, resource, so as to execute successful audit as per schedule.

• To outline and circulate audit agenda prior to audit. The Audit Agenda shall be prepared based on reason behind conducting GMP audit, e.g. Qualification, Surveillance or For-Cause Audit.

• To execute on-site audit through facility visit and review of quality management systems established in various functions such as Material Management, Production & Packing, Facility & Equipment, Quality Systems and Quality Control Laboratory, including microbiology lab, as applicable.

• To communicate the outcome of CMO / vendor audit, based on the risk associated with the patient, regulatory compliance and business risk, to facilitate making decision of Vendor Approval / Dis-approval.

• To make sure that CMO sites and Affiliate Companies are prepared for Regulatory Agency Inspections e.g. through "Mock" inspections, audits and supports activities whenever required.

• 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 ensure during audit that, non-compliances to the requirements stated in various guidelines have been identified.

• 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 review & approved the audit report, closure, as applicable. 

• To maintain evidences and documents related to audit.

• To prepare Monthly report and to highlight the key area of concerns.

• To participate in the trainings to update on current / upcoming regulations.

• Trending the audit observations and highlighting the areas for improvement.

• To follow the Corporate Quality Policies/ Global Quality Standards (GQS) and applicable Regulatory Guidelines.

• Participate and execute the project work as allotted by reporting authority.

• To perform the CMO risk assessment.

Requirements and Qualifications:

Industrial Experience & Knowledge:   

• R&D, Production, Quality Assurance experience in Bio-pharmaceutical/Pharmaceutical with 13.10 years of experience.

• ISO 9001:2015 certified lead Auditor.

• Processes Known: Inspection readiness, Life cycle of the product from process development phase to commercialization phase with successful clearance of regulatory inspection.

• Succeeding cGMP, Root Cause Investigations, Implementation of CAPA, OOS/Deviation Management, Change management, Auditing, Compliant Handling and Process Optimization.

Travel Estimate

Low

Job Requirements

Educational Qualification

Bachelors or Masters degree 

Experience

13+ years’ experience

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).