Senior Executive

Sun Pharmaceutical Industries, Inc.; Jammu district; On-site; INR 900,000 - 1,700,000; Full time

Job summary

Sun Pharmaceutical Industries, Inc. is seeking a QA/QMS-focused professional to uphold cGMP standards across manufacturing operations in India. You will manage deviations, investigations, CAPA, and trend analysis to drive continuous improvement and regulatory compliance.

You will collaborate with QA, QC, Production, Maintenance, Engineering, and HR to maintain training records, ensure GDP adherence, and support audits and inspections. B.Pharma / M.Pharma is required.

Qualifications

• GxP, GDP and cGMP knowledge required.
• Experience in deviation/ investigation processes in manufacturing.
• Capable of leading CAPA implementation with cross-functional teams.
• Maintain QMS documentation and training records.
• Proficient in data analysis and trend reporting.

Responsibilities

• Manage deviation and investigation processes across manufacturing operations.
• Drive root cause investigations and ensure timely closure of quality events.
• Implement CAPA with cross-functional teams and monitor effectiveness.
• Prepare and analyze trend reports for deviations, OOS, OOT, and complaints.
• Ensure GDP, GxP compliance and maintain quality records.
• Coordinate with QA, QC, Production, Maintenance, Engineering, and HR.
• Support audits and regulatory inspections.
• Provide guidance on QMS processes and drive continuous improvement.

Skills

GxP knowledge

GDP knowledge

cGMP compliance

CAPA implementation

Deviation investigations

Education

B.Pharma / M.Pharma

Tools

SAP

Job description

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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:

• Manage Deviation and Investigation processes across manufacturing operations, including planned/unplanned deviations, OOS (Out of Specification), OOT (Out of Trend), and market complaints.
• Drive root cause investigations and ensure timely closure of all quality events in compliance with regulatory expectations.
• CAPA (Corrective and Preventive Actions) implementation in collaboration with cross-functional teams (CFTs), ensuring proper implementation and effectiveness monitoring.
• Prepare and analyze trend reports for deviations, OOS, OOT, and complaints to identify recurring issues and systemic gaps.
• Ensure strict adherence to Good Documentation Practices (GDP) for all GxP-related records and documentation.
• Perform periodic and random report verification to confirm compliance with quality standards and procedures.
• Utilize SAP systems for retrieval and assessment of data related to raw materials, packing materials, semi-finished goods (SFG), and finished goods (FG) for QMS investigations.
• Ensure compliance with cGMP, regulatory guidelines, and internal quality standards at all times.
• Maintain accurate and up-to-date records in quality management systems and trackers for deviations, CAPA, change controls, and investigations.
• Collaborate effectively with QA, QC, Production, Maintenance, Engineering, and HR departments to ensure seamless execution of QMS processes.
• Facilitate cross-functional meetings for investigation closure, CAPA implementation, and continuous improvement initiatives.
• Coordinate and monitor training programs related to QMS, including both classroom and electronic systems (LMS).
• Ensure timely completion of QMS-related training by employees and maintain proper training records.
• Execute track-wise activities (e.g., deviations, change controls) and ensure timely updates in relevant systems.
• Support internal and external audits, regulatory inspections, and ensure timely closure of audit observations.
• To maintain hygienic practices like no eating, no chewing, no smoking, no storage of food in manufacturing area, no self-medication and good sanitation practices etc.
• Adheres to all cGMPs, compliance/regulatory mandates and quality requirements.
• Provide guidance and direction to team members on QMS processes and compliance expectations.
• Assists in the identification and implementation of continuous improvement opportunities.

Performs other related jobs as assigned by seniors to meet departmental and Company

Job Requirements

Educational Qualification

B.Pharma / M.Pharma

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 this duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).