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:
- Accountable for ensuring OSD quality compliance activities at the site.
- Managed the Third-party consultant at site
- Oversee regulatory audits, including preparation of responses and closure of commitments.
- Manage corporate audits along with response submission and timely closure of commitments.
- Handle customer audits, ensuring effective responses and completion of all commitments.
- Lead and coordinate OSD remediation activities at the site.
- Drive and manage global CAPA initiatives.
- Oversee vendor qualification management for sterile and OSD products, including APIs, excipients, and packaging materials.
- Lead site internal inspections, ensuring proper management and timely escalation of issues.
- Manage contract service providers for both sterile and OSD functions.
- Handle nitrosamine assessment activities, including timely escalation of concerns.
- Support and manage Management Review Board activities related to inspections.
- Lead critical and data integrity investigations, and review CAPA effectiveness.
- Conduct gap assessments related to guidelines, FDA 483 observations, and other Sun network site observations.
- Review the periodic quality system and escalation on timely manner.
- Review and approve SOPs for the compliance department.
