Senior Executive

Sun Pharma; Kalol; On-site; INR 1,100,000 - 1,700,000; Full time

Job summary

Sun Pharma in Halol-I invites experienced professionals for the Sr. Executive role in the SGO unit. You will manage vendors, oversee SAP-based processes, and ensure compliance with cGMP standards.

The position requires a MSc/M. Pharma and 7+ years of relevant experience, with exposure to regulatory inspections and CAPA processes. Join Sun Pharma to contribute to quality, training, and continuous improvement at the site.

Qualifications

• MSc/M. Pharma is required.
• 7+ years of experience in pharma/CGMP.
• Experience with regulatory inspections and CAPA processes.

Responsibilities

• Handle overall management of vendors incl. raw material and packaging materials; SAP-based monitoring.
• Manage contract service providers and ensure timely responses to observations.
• Monitor CAPA planning and ensure timely closures and reviews.
• Oversee compliance actions arising from regulatory inspections and external audits.
• Ensure cGMP activities at site and compliance with quality systems.
• Share and implement learnings from audits and global standards via training programs.
• Perform gap assessments and update procedures for GQSs/GSOPs; lead department training.
• Manage internal and external quality audits and inspection readiness.
• Support inspection management and act as scribe during regulatory/ external inspections.
• Lead inspection teams and SMEs during inspections.
• Monitor site risk assessment periodically for compliance.

Skills

Vendor management

Education

MSc /M. Pharma

Tools

SAP

Job description

Title:

Sr. Executive

Business Unit:

SGO

Job Grade

G11B

Location:

Halol-I

Key Responsibilities

1. Handling Overall Management of Vendors: Raw Material and Packaging Materials and Managed in SAP.
2. Handling of Contract Service Provider
3. Facilitate for timely preparation, review and adequate response to the Observation and monitor CAPA planner for it timely closures.
4. Monitoring and tracking of various compliance actions arises due to regulatory inspections and external audits.
5. Responsible for monitoring of cGMP activities at site and to have the oversight, monitoring and compliance with quality system.
6. To share and implement learning from internal/external audits, guidelines, Global Standards through specific training programs to improve cGMP and incorporate them in site SOPs
7. To perform gap assessment and revision of procedure as needed for Implementation of GQSs/GSOPs related to department and lead the Training function for the department
8. Handling of Internal and External Quality Audit.
9. Review and support for inspection management.
10. Lead the role of scribe in the regulatory and External inspection
11. Management of inspection team and SMEs during inspection
12. Monitoring of site risk assessment periodically for compliance

Job Requirements

Educational Qualification

MSc /M. Pharma

Experience

7+ years

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).