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Senior Executive - Manufacturing Qms

Amneal
Amneal
0-2 years
Not Disclosed
10 Oct. 3, 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 – Manufacturing (QMS)

📍 Location: Ahmedabad City, Gujarat, India
🕓 Job Schedule: Full-Time
🧾 Job Category: Manufacturing Process Operations
🎓 Qualification: B. Pharm
📅 Posting Date: 29/09/2025, 04:13 PM
📅 Apply Before: 31/12/2025, 04:13 PM
🆔 Job Identification: 6578
🏢 Workplace Address: Survey No.506, At-Palli, Mehsana, Gujarat – 382165


🔹 Key Responsibilities:

🧼 Compliance & Hygiene

  • Maintain personal hygiene and ensure adherence to cGMP, GDP, and departmental discipline.

  • Ensure consistent compliance with quality and safety standards.

📘 Documentation & Review

  • Prepare and review Master Documents, Protocols, and Reports for production as per organizational requirements.

  • Manage Exhibit Batch Documents including BMRs (Batch Manufacturing Records) and BPRs (Batch Packaging Records).

  • Review BMR, BPR, and other Exhibit Batch-related documents for accuracy and compliance.

🧭 Quality Management System (QMS) Activities

  • Handle Change Control, Deviations, CAPA (Corrective and Preventive Actions), and Investigations as per SOPs.

  • Ensure timely closure and proper documentation of all QMS-related activities.

🧑‍🏫 Training & Development

  • Conduct training sessions for subordinates, technicians, and operators within the department.

  • Attend all scheduled training programs as per Training Schedule and TNI (Training Need Identification).

  • Ensure team members are trained and competent in their respective tasks.

⚙️ Other Responsibilities

  • Perform additional activities as directed by the Head of Department (HOD).

  • Support continuous improvement initiatives in manufacturing and QMS.


🔹 Required Skills:

  • Change Control Management

  • Deviation Handling

  • CAPA Implementation

  • Investigation Techniques

  • BMR/BPR Preparation & Review

  • SOP Compliance


📢 Note:

The ideal candidate should possess strong documentation skills, in-depth knowledge of QMS, and the ability to train and lead manufacturing teams in a regulated pharmaceutical environment.