Sun Pharma is India’s No. 1 pharmaceutical company and a leading global player in specialty medicines. With over 40 manufacturing facilities and a diverse portfolio, we deliver high-quality medicines across 100 countries. Driven by a commitment to innovation, we continuously strive to enhance access to medicines and improve patient care, creating better health outcomes for millions around the world.
Post : Manager - EU Compliance
Key responsibilities : The EU Compliance Specialist will be responsible for supporting EU-related activities in the Sun India DF site which manufacture products for the EU and UK markets. Documents related to EU-products such as (but not limited to) Change Controls (including Temporary CC’s), Market Complaints, Investigations associated with Deviations, OOS/OOT shall be screened for robustness prior to sharing with the EU QP teams. Supporting site compliance to EU-GMP Guidelines and their implementation, in addition to supporting ad-hoc requests from the EU Compliance Lead and/or EU QP and Compliance teams will be required.
Major Tasks & Responsibilities
• Assess all site investigation related to EU-products for completeness and robustness
• Liaise with the EU Compliance Lead on all matters of concern related to EU GMP’s and EU-products.
• Triage investigations at site related to EU products and confirm accuracy of classification by site.
• Ensure all Change Controls with major or critical impact (impact to either product process validation status or marketing Authorisation) are shared for pre-approval by the EU QP’s.
• Maintain open and effective communication channels between India Sites (EU supplying) and EU Compliance Lead so that information flowing to EU QP’s is accurate.
• Ensure regular communication cadence with the EU-Compliance Lead
• Support quality operations when required and aligned with EU-Compliance Lead and/or EU QP’s and Head of Compliance WEU.
• Ensure timely communications with both India and EU stakeholders according to the requirements of Quality Agreements.
• Support the maintenance and update of the local site Quality Management System as aligned with EU-Compliance Lead
Candidate Profile
• Bachelor Degree in (Bio-) Chemistry, Pharmacy, Biotechnology or similar education
• Tenure : Minimum 8 to 10 years
• Industry : (Bio) pharmaceutical, sterile manufacturing (as required per site)
• Content areas: Manufacturing, QA /QC. QA manufacturing operation
• Experience on review of batch documentation and preparation for batch certification.
• Good experience and knowledge of QA/QC and EU regulatory compliance
• Good knowledge and experience in DF pharmaceutical processes and QA/QC operations.
• Good understanding of change control processes and interaction with regulatory affair processes.
• Capable of reviewing and assessing manufacturing and analytical technical documents and provide sound quality assessments on change controls, deviations and complaints.
• Experience working with electronic Document Management, electronic Training systems and e.g. Trackwise
• Understanding of risk assessment and risk management fundamentals/tools
• Experience interacting with external parties.
• Good knowledge of MS office and Windows based computer applications.
• Strong interpersonal skills, excellent communication skills, good presentation, negotiations and influencing skills
• Ability to effectively manage multiple, complex priorities and quick shifting of those.
• Team player, task oriented and keen on working in a cross-cultural working environment.
Additional Information
Experience : 8 to 10 years
Qualification : Bachelor Degree in (Bio-) Chemistry, Pharmacy, Biotechnology
Location : Tandalja - R&D
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 20th May 2026
EU Compliance Manager : Apply Online
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