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Senior Executive - Granulation

7+ years
Not Disclosed
10 Oct. 2, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Executive – Granulation

📍 Location: Ahmedabad City, Gujarat, India (and one additional location)
🎓 Education: B.Pharm
🧠 Experience: Minimum 7 years in Granulation


🏢 About the Role

The Senior Executive – Granulation is responsible for the supervision and execution of manufacturing, processing, packaging, and holding activities of drug products in compliance with cGMP standards. This role ensures smooth batch operations, accurate documentation, equipment qualification, and team training to support the production of stability and commercial batches.


💼 Key Responsibilities

🔹 Manufacturing & Supervision

  • Supervise manufacturing, processing, packaging, and holding of drug products as per approved procedures.

  • Ensure smooth execution of stability and commercial batch activities.

  • Maintain compliance with all cGMP and SOP requirements.

🔹 Area & Equipment Maintenance

  • Maintain all production areas and equipment in a clean, orderly, and sanitized condition.

  • Ensure all equipment remains in a good state of repair and ready for use.

🔹 Documentation & Compliance

  • Perform online documentation as per Good Documentation Practices (GDP).

  • Review and implement:

    • Batch Manufacturing Records (BMR)

    • Batch Packaging Records (BPR)

    • Process Study Protocols and Reports

    • All other relevant manufacturing documents

🔹 Training & Team Development

  • Provide training on operation and cleaning SOPs to subordinates and operators.

  • Ensure all team members adhere to SOPs and safety standards.

🔹 Equipment Qualification

  • Coordinate and support Installation Qualification (IQ) and Operational Qualification (OQ) for new equipment and systems.

  • Perform Performance Qualification (PQ) for all newly installed equipment.

🔹 Material Management

  • Manage material movement as per approved procedures and BMR/BPR.

  • Ensure traceability and proper documentation of all materials used in production.

🔹 Safety & Compliance

  • Follow all departmental SOPs, safety rules, and general instructions.

  • Maintain a culture of safety, quality, and compliance on the shop floor.

🔹 Additional Responsibilities

  • Perform any other tasks or duties as assigned by the Head of Department (HOD), following proper guidance and instructions.


Key Skills & Competencies

  • Strong knowledge of Granulation process and cGMP standards.

  • Expertise in BMR/BPR review, equipment qualification, and batch execution.

  • Good understanding of SOPs, GDP, and safety practices.

  • Excellent communication and team leadership skills.

  • Ability to troubleshoot process issues and drive continuous improvement.