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:
- Responsible for monitoring of cGMP activities at site and to have the oversight, monitoring and compliance with quality system.
- 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:
- To perform GMP round for non-Sterile manufacturing facility.
Auditor:
- To perform internal and external (Vendor) audit as an auditor.
- To prepare observation report in timely manner.
- To review observations and responses for audits.
Inspection:
- Handling of Internal and External Quality Audit.
- Review and support inspection management.
- Co-ordinate the pre-inspection process.
- Management of inspection team and SMEs during inspection.
- Draft, facilitate and ensure timely inspection response and monitor CAPA timelines.
- Monitoring and tracking of various compliance actions arises due to regulatory inspections and internal/customer audits.
Readiness:
- Proactively assess quality issues at site and ensure compliance to QA regulatory requirements in manufacturing operations at site.
- Facilitate internal and regulatory agency audits, ensuring that findings from site audits are understood assessed and addressed site wide in a comprehensive manner.
- Gap assessment of newly / updated regulatory guidance and regulatory observations.
- Gap identification and assessment on site against globally observed 483.
Global CAPA:
- Assessment of global CAPA received from corporate and gap assessment and implementation at site.
GQSs/GSOPs:
- To perform gap assessment and revision of procedure as needed for Implementation of GQSs/GSOPs related to department.
Risk Assessment:
- Monitoring of site risk assessment periodically for compliance.
Periodic Compliance review meeting coordinator:
- Distribute the meeting agenda to all members in advance of the scheduled meeting.
- Collect the review outcome from quality compliance team and prepare the consolidated meeting presentation.
- Distribute minutes of meeting to all members.
- Sign the presentation after periodic quality compliance review meeting.
Other Responsibilities:
- Responsible for carrying out any other responsibilities assigned form Department head, time to time orally or in writing.
