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

Create your own sunshine

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:

SUN Pharma Quality and Compliance Standards, and applicable global regulatory authorities’ requirements are met and that all SUN affiliates

Essential Job Functions:

GMP Audit of Contract Manufacturing Organization (CMO) sites

• 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.

outline and circulate audit agenda prior to audit

execute on-site audit

• 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.

Planner, Schedule, Audit Report

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: