Executive - API

Title : Executive - API

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).

Job Segment : Engineer, Engineering

Skills Required

Cleaning Validation, Change Control, Risk Assessment, Technology Transfer