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Compliance Management Specialist
2 weeks ago
SUN PHARMA is a leading pharmaceutical company committed to delivering high-quality products and services.
Job Description
We are seeking an experienced Compliance Manager to join our team. As a key member of our compliance department, you will play a crucial role in ensuring that our operations meet the highest standards of quality, safety, and regulatory compliance.
Required Skills and Qualifications
To be successful in this role, you will need:
- 14+ years of experience in microbial and sterile processing
- MSc / B.Pharm / M.pharm qualification
- Excellent knowledge of quality audit processes and regulatory requirements
- Strong leadership and communication skills
Key Responsibilities
Your key responsibilities will include:
- Handling internal and external quality audits
- Coordinating pre-inspection processes with CFT coordinations
- Managing inspection teams and SMEs during inspections
- Drafting, facilitating, and ensuring timely inspection responses and monitoring CAPA timelines
- Monitoring and tracking compliance actions arising from regulatory inspections and internal/customer audits
- Performing self-inspections and gap assessments of regulatory guidance and observations
Benefits
In return for your expertise and dedication, we offer a competitive salary package, excellent benefits, and opportunities for professional growth and development.