- Location
- Bavla, Gujarat, India
- Job type
- Full-time
Required skills
- API
- compliance
- specification
About the role
Dishman Carbogen Amcis Ltd
Website:
dishmangroup.com
Job details:
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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