Senior Officer - Production - Halol II

SUN PHARMA; Panchmahal District; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Sun Pharma in Halol, Gujarat invites an Executive to drive MES validation and quality oversight. You will oversee IQ/OQ/PQ validation activities, ensure data integrity, and support regulatory compliance. The role includes updating SOPs, managing BMR/BPR changes, and representing quality during audits.

You will contribute to continuous improvement of MES workflows and maintain inspection readiness. 2+ years of relevant experience and a B.Pharm / M.Pharm degree are expected.

Qualifications

• B.Pharm / M.Pharm educational qualification.
• Experience: 2+ years.

Responsibilities

• Lead/oversee validation activities (IQ/OQ/PQ) for MES, ensuring compliance with regulatory requirements (21 CFR Part 11, Annex 11, GAMP 5).
• Monitor MES operations to ensure compliance with SOPs, batch records, and data integrity (ALCOA+).
• Create/amend SOPs for MES and lead changes to BMR/BPR for simplification & reorganization; approve MES documents.
• Act as quality representative during internal and external audits (e.g., FDA, EMA) and maintain inspection readiness for MES processes.
• Identify opportunities to optimize MES workflows for compliance and efficiency.

Education

B.Pharm / M.Pharm

Job description

Job Description:

Job Title:	Executive	Business Unit:	Sun Global Operations
Job Grade	G12A	Location :	Halol 2
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.
Travel Estimate
Job Requirements
Educational Qualification	B.Pharm / M.Pharm
Experience	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!
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).

Requirements: