Compliance and Audit Lead
1 week ago
**Job Overview**
SUN PHARMA is seeking a highly skilled Compliance and Audit Lead to join our team. As a key member of the organization, you will be responsible for ensuring compliance with regulatory requirements and company standards.
**Responsibilities:**
- Lead site internal, corporate, external, customer, and regulatory inspections and responses.
- Foster support to ensure achievement of accountabilities for team members of the compliance group at the site.
- Oversee the compliance team at the site to ensure overall compliance to SUN PHARMA standards and cGxP requirements.
- Facilitate review and support regulatory inspection management.
- Lead the support team for major health authority inspections at the site and provide input & support to inspection responses to drive consistency and clarity at the site.
- Ensure timely preparation of inspection response and monitor implementation of various compliance actions / CAPA arising due to regulatory inspections and internal/customer audits.
- Collaborate with the corporate compliance group and site team to resolve issues in implementing global CAPA.
- Review Global CAPA issued, internally communicate, and ensure effective implementation of global CAPA.
- Facilitate, review, and monitor cross-functional investigation teams.
- Regularly evaluate and report compliance status of the site to the Site Quality Head / Quality Cluster Head.
- Responsible for approval of investigation plan to proceed for critical investigations.
- Support compliance investigations as needed in collaboration with others at the site.
- 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.
- Responsible for on-time Health Authority notifications, Field alert report, and Recall management.
- Responsible for self-inspection (Internal Audits) management at the site and ensure self-inspection of all quality systems & sub-systems are performed at the site in accordance with established SOPs & SUN PHARMA global quality policy / standards.
- Responsible to perform internal audit as per site-specific procedures.
- Perform 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.
**Requirements:**
- B.Pharm / M.Pharm degree required.
- 17 to 20 years of experience with regulatory experience in OSD.
**Estimated Salary Range: $80,000 - $120,000 per annum**, depending on location and qualifications.
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