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:
- Responsible for monitoring of all cGMP activities at site.
- Facilitate review and support regulatory inspection management.
- Monitoring and tracking of various compliance actions arises due to regulatory inspections and internal\customer audits.
- Draft, facilitate and ensure timely inspection response and monitor CAPA timelines.
- Collaborate with Corporate compliance group and implement global CAPA.
- Facilitate, review and monitor cross functional investigation teams.
- Support plant for management of compliance activities.
- Regularly evaluate and report compliance status of site to Site Quality Head.
- Support for major health authority inspections at site and provide input and support to inspection responses to drive consistency and clarity at the site.
- Support compliance investigations as needed in collaboration with others at the site.
- Provide oversight of quality activity outcomes resulting from regulatory inspections, commitments and filings.
- Provide support in execution and monitoring of remediation compliance through compliance verification audits.
- Responsible for all compliance and bringing solutions to compliance related issues within the site.
- Review Regulatory inspection observations, trend and decide compliance strategy.
- Educate and institutionalize a culture of Quality and compliance at the site.
- Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence. Performs all work in accordance with all established regulatory and compliance and safety requirements.
- Provide appropriate training and development to support staff to meet their respective job responsibility.
- To perform Gap Assessment for assessment of internal and external corporate compliance report for all 483's & warning letters against the site and to ensure compliance as per SOP.
- To perform self-inspection (Internal Audits) for all quality systems & sub systems at the site.
