Manager 2-Quality Assurance

Title:

Manager 2-Quality Assurance

Business Unit:

Global Quality and Compliance

Job Grade

G11A /Manager-2

Location:

Mohali

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.

Position Summary -

• Implement, operate, monitor and maintain Quality Systems which enable operations on site to occur in an efficient manner and in compliance with Global Quality Standards and cGMPs.
• Review and Archival of Quality System documents.
• Follow up for timely closure of Quality Management System documents.
• Participating in the investigation analysis for Deviations, OOS, OOT, Complaints and Audit finding, moreover responsible for providing batch disposition decision as per the outcome of Deviation, OOS and OOT investigation.
• Supporting in external audits preparations and responding to audit findings.
• Compilation of the Internal audits response and follow up.
• Assist in scheduling and preparation of management review meetings.
• Organize the CAPA meeting, coordinate/manage CAPA efforts and interact with customers to conduct complaint investigations.
• Handling of Change Management CAPA Management System.
• Assist to author, review and update quality procedures as applicable.
• Responsible for Handling of Complaints, Mock recall/Recall and withdrawal of Drug Products.
• Retentions Sample Management.
• Preparation of APR/PQR.

Travel Estimate

Low

Job Requirements

Educational Qualification

Pharmacy (M. Pharma/M. Sc. /B. Sc. /B. Pharma)

Experience

12-15 years of relevant experience in OSD manufacturing

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).