
Sun Pharmaceutical Industries Ltd., India’s leading pharmaceutical company, is inviting applications for the position of Manager – EU Compliance. This critical role is based at the Tandalja R&D site and focuses on ensuring that manufacturing and quality documentation meet the stringent standards required for the EU and UK markets.
As an EU Compliance specialist, you will act as a vital bridge between Indian manufacturing sites and the EU Qualified Person (QP) teams, ensuring that every product destined for European markets adheres to EU-GMP guidelines.
Key Responsibilities
- Documentation Oversight: Screen and assess Change Controls, Market Complaints, and investigations (Deviations, OOS/OOT) for robustness and completeness before they reach EU QP teams.
- EU-GMP Alignment: Support the implementation of EU-GMP Guidelines across the site and maintain the local Quality Management System (QMS).
- Triage & Classification: Manage site investigations related to EU products, confirming accurate classification and ensuring high-impact Change Controls receive necessary pre-approval from EU QPs.
- Stakeholder Communication: Maintain seamless communication between India-based sites and the EU Compliance Lead. Ensure all data shared with EU QPs is accurate and follows Quality Agreements.
- Technical Assessment: Provide sound quality assessments on manufacturing and analytical technical documents, utilizing risk management fundamentals.
Candidate Profile
- Education: Bachelor’s degree in Pharmacy, (Bio-) Chemistry, Biotechnology, or a related field.
- Experience: Minimum 8 to 10 years in the (bio)pharmaceutical industry, specifically within Manufacturing, QA/QC, or sterile manufacturing.
- Technical Skills: * Strong knowledge of EU regulatory compliance and DF pharmaceutical processes.
- Proficiency in electronic systems like Trackwise, Document Management, and Training systems.
- Expertise in reviewing batch documentation and change control processes.
- Soft Skills: Excellent negotiation, influencing, and cross-cultural communication skills. Ability to manage multiple complex priorities in a fast-paced environment.
Position Details
- Location: Tandalja – R&D, Vadodara, Gujarat.
- Functional Area: Quality / R&D.
- Industry Type: Pharma / Healthcare / Clinical Research.
- Application Deadline: 20th May 2026.
How to Apply
Eligible professionals should apply through the official Sun Pharma careers portal.
Expert Insight: For this role, Sun Pharma is looking for a “Gatekeeper.” In your application, emphasize your experience in defending site investigations during audits or your success in streamlining the communication flow between local sites and international regulatory bodies.
