Manager - Quality Engineering

About Sun Pharma and Role Overview

At Sun Pharma, we encourage you to "Create your own sunshine" by fostering an environment that supports growth, ownership, and collaboration. Join us to continuously improve yourself, lead confidently, and contribute as part of a thriving team.

Key Responsibilities

• Lead qualification activities for processes and equipment including vial washing, depyrogenation, filtration, filling, manufacturing, lyophilizer operations, component washing and sterilization, terminal sterilization, isolators, CIP SIP skid, leak testing, X-ray inspection, VHP, and clean utilities such as steam, compressed air, PW and WFI generation systems, AHU, and FFM.
• Manage design and qualification of process equipment like vial washing machines, tunnel sterilizers, filling machines, capping machines, lyophilizer loading/unloading systems, filtration skids, manufacturing and dispensing isolators, pH and DO meters, integrity testers, autoclaves, terminal sterilizers, ultrasonication machines, GMP washers, external washing machines, leak test and X-ray inspection devices, and packing machines.
• Oversee design and qualification of utilities including pure steam generation/distribution, purified water and WFI systems, nitrogen and compressed air generation/distribution, AHU, FFM, LAF, controlled areas, and cold storage.
• Coordinate procurement of equipment and accessories necessary for qualification activities.
• Prepare, review, and execute qualification protocols such as URS, DQ, IQ, OQ, PQ, and computer system validation.
• Develop schedules for qualification, calibration, requalification activities and maintain status updates for qualification labeling.
• Create and review SOPs related to qualification and process equipment operations.
• Manage QMS documentation including change controls, CAPA, risk assessments, and deviations.
• Communicate effectively with vendors and procurement teams concerning equipment design details.
• Ensure documentation and activities adhere to cGMP compliance standards.
• Handle issuance, retrieval, and secure storage of qualification documents.
• Plan and execute qualification activities ensuring proper manpower allocation.
• Interact with regulatory auditors from agencies such as USFDA, EU, ANVISA, and Canada as necessary.
• Travel as required for job responsibilities.

Educational and Experience Requirements

• Minimum qualification: B. Pharmacy or M. Pharmacy.
• Relevant work experience: 12 to 14 years in the pharmaceutical industry focusing on quality engineering or related function.

Our Commitment

Sun Pharma prioritizes your success and well-being by providing a supportive environment with ample benefits and growth opportunities, allowing you to collaborate and make meaningful contributions daily.

Disclaimer

This job description outlines the general duties and responsibilities of the role. It may be revised or adjusted depending on business needs, and comparable responsibilities may be assigned consistent with the employee's qualifications and experience.