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:
1. Compliance ( shared with QA IT ) - Lead/oversee validation activities (IQ/OQ/PQ) for MES, ensuring adherence to regulatory requirements (21 CFR Part 11, Annex 11, GAMP 5). Review and approve validation protocols, reports, and change controls.
2. Quality Oversight: Monitor MES operations to ensure compliance with SOPs, batch records, and data integrity (ALCOA+ principles). Investigate and resolve deviations, discrepancies, and CAPA related to MES.
3. Documentation & Change Management: Create/amend SOPs as applicable for MES
Lead the initiative for the changes required in `BMR/BPR for simplification & reorganizing it
Approve MES-related documents (SOPs, work instructions) and ensure audit-ready records.
Assess the quality impact of system changes and manage change control processes.
4. Audit & Inspection Support:
Act as the quality representative during internal and external audits (e.g., FDA, EMA).
Maintain inspection readiness for MES processes and documentation
5. Continuous Improvement:
Identify opportunities to optimize MES workflows for compliance and efficiency.
