Executive - Api

1 week ago

Bavla Ahmedabad Gujarat, India Dishman Carbogen Amcis Full time

**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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