Manager - Compliance (OSD)

Job Title:

Manager Compliance

Business Unit:

Global Quality & Compliance

Job Grade

G10

Location :

Halol 2

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.”

Key responsibilities:

cGMP:

1. Responsible for monitoring of cGMP activities at site and to have the oversight, monitoring and compliance with quality system.
2. 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.

Gemba:

1. To perform GMP round for non-Sterile manufacturing facility.

Auditor:

1. To perform internal and external (Vendor) audit as an auditor.
2. To prepare observation report in timely manner.
3. To review observations and responses for audits.

Inspection:

1. Handling of Internal and External Quality Audit.
2. Review and support inspection management.
3. Co-ordinate the pre-inspection process.
4. Management of inspection team and SMEs during inspection.
5. Draft, facilitate and ensure timely inspection response and monitor CAPA timelines.
6. Monitoring and tracking of various compliance actions arises due to regulatory inspections and internal/customer audits.

Readiness:

1. Proactively assess quality issues at site and ensure compliance to QA regulatory requirements in manufacturing operations at site.
2. Facilitate internal and regulatory agency audits, ensuring that findings from site audits are understood assessed and addressed site wide in a comprehensive manner.
3. Gap assessment of newly / updated regulatory guidance and regulatory observations.
4. Gap identification and assessment on site against globally observed 483.

Global CAPA:

1. Assessment of global CAPA received from corporate and gap assessment and implementation at site.

GQSs/GSOPs:

1. To perform gap assessment and revision of procedure as needed for Implementation of GQSs/GSOPs related to department.

Risk Assessment:

1. Monitoring of site risk assessment periodically for compliance.

Periodic Compliance review meeting coordinator:

1. Distribute the meeting agenda to all members in advance of the scheduled meeting.
2. Collect the review outcome from quality compliance team and prepare the consolidated meeting presentation.
3. Distribute minutes of meeting to all members.
4. Sign the presentation after periodic quality compliance review meeting.

Other Responsibilities:

1. Responsible for carrying out any other responsibilities assigned form Department head, time to time orally or in writing.

Travel Estimate

Job Requirements

Educational Qualification

B.Pharm / M.Pharm

Experience

12-14 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).