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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

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