Executive - API

1 week ago


Bavla Ahmedabad Gujarat, India Dishman Carbogen Amcis Ltd Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Custom Field 2: 2869

Location:Bavla, Gujarat, IN

Country/Region: IN

State: Guja

City: Bavla

Company: Dishman Carbogen Amcis Limited

Business Unit: General

Travel:

Description:

  • Prepare and review Standard Operating Procedures (SOPs).
  • Review Batch Manufacturing Records (BMR), Batch Packing Records (BPR), Engineering Change Requests (ECR), and Process Flow Diagrams (PFD).
  • Manage Change Control activities.
  • Prepare and review Annual Product Quality Reviews (APQR).
  • Assist in product release activities.
  • Oversee Process Performance Qualification (PPQ) and Cleaning Validation.
  • Handle and document Deviations.
  • Investigate Out of Specification (OOS) and Out of Trend (OOT) results related to manufacturing.
  • Prepare and review Risk Assessment reports.
  • Review Line Clearance activities.
  • Participate in Technology Transfer processes.
  • Review Qualification documents.
  • Perform sampling activities.
  • Ensure compliance with Safety, Health, and Environmental norms, including proper use of personal protective equipment (PPE).

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