Title:  Manager - 2

Job Title:

Section Head - IPQA

Business Unit:

Global Quality And Compliance

Job Grade

G11A

Location :

Jammu

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 will 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.”

Key responsibilities:

• To lead and manage all IPQA activities across manufacturing operations, ensuring compliance with cGMP, regulatory requirements, and internal quality systems. The role is responsible for maintaining product quality through real-time monitoring of processes and driving continuous improvement.
•  Oversee IPQA activities in production areas (granulation, compression, coating, packing, etc.).Ensure in-process checks are conducted as per approved SOPs, BMR/BPR, and regulatory requirements.Provide real-time quality oversight during manufacturing operations.Ensure line clearance, area clearance, and equipment verification before operations.
• Participate in internal and external audits and ensure audit readiness.Handle regulatory inspections and respond to observations related to IPQA.
• Review and approve BMRs (Batch Manufacturing Records) and BPRs (Batch Packing Records).Ensure accurate documentation of in-process observations and deviations.Monitor and ensure proper logbook entries and adherence to documentation practices.
• Lead investigation of deviations, OOS (Out of Specification), and OOT (Out of Trend).Ensure root cause analysis (RCA) and implementation of effective CAPA.Review and approve change control proposals impacting manufacturing processes.Track and monitor closure of deviations and CAPAs.
• Monitor critical process parameters (CPP) and critical quality attributes (CQA).Identify trends and recommend process improvements.Coordinate with production, QC, and engineering teams to enhance quality performance.
• Conduct routine shop floor compliance checks.Verify status labeling of materials, equipment, and areas.
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Travel Estimate

Job Requirements

Educational Qualification

B.Pharma/M.pharma

Experience

10-15 Yrs experience in regulated pharma industry and minimum 2-3 years in IPQA as lead role 

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).