At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an workplace 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.