Senior Officer - Production - Halol II

Sun Pharmaceutical Industries, Inc.; halola; Vor Ort; INR 600.000 - 900.000; Vollzeit

Zusammenfassung

Sun Pharmaceutical Industries Ltd is seeking a Senior Officer - Production at Halol II. The role involves leading MES validation activities (IQ/OQ/PQ) to ensure compliance with 21 CFR Part 11, Annex 11, and GAMP 5, while overseeing quality and data integrity for MES operations.

Responsibilities include creating and approving SOPs for MES, managing changes to BMR/BPR, and acting as the quality representative during audits such as FDA and EMA, with readiness for inspections at all times.

Qualifikationen

• B.Pharm or M.Pharm degree required.
• 2+ years of relevant experience.

Aufgaben

• Lead / oversee MES validation activities (IQ/OQ/PQ) and ensure compliance with regulatory requirements (21 CFR Part 11, Annex 11, GAMP 5).
• Monitor MES operations for SOPs, batch records, and data integrity; investigate deviations and CAPA related to MES.
• Create / amend SOPs for MES; drive changes in BMR/BPR for simplification and reorganization; approve MES documents and ensure audit-ready records.
• Act as quality representative during internal and external audits (FDA, EMA) and maintain inspection readiness for MES processes and documentation.
• Identify opportunities to optimize MES workflows for compliance and efficiency.

Ausbildung

B.Pharm / M.Pharm

Jobbeschreibung

Title: Senior Officer - Production - Halol II

Date: Oct 23, 2026

Location: Halol 2 - Operations Block A

Company: Sun Pharmaceutical Industries Ltd

Job Title:

Executive

Business Unit:

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:

• 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

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).