Job Description
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.