Senior Officer - Production - Halol II

Are You Ready to Create Your Own Sunshine?

Key responsibilities:

• 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. 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. 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. 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 Continuous Improvement: Identify opportunities to optimize MES workflows for compliance and efficiency.
• Travel Estimate
• 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.
• 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.
• 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.
• 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
• Continuous Improvement:
• Identify opportunities to optimize MES workflows for compliance and efficiency.

Job Requirements

• Educational Qualification
• B.Pharm / M.Pharm
• 2+ years
• Your Success Matters to Us
• At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Experience

• Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).