Executive - API

Dishman Carbogen Amcis Ltd

0 years

0 Lacs

india

Posted:3 days ago| Platform: Foundit logo

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Skills Required

cleaning validation qualification documents change control risk assessment technology transfer line clearance sampling activities

Work Mode

On-site

Job Type

Full Time

Job Description

Title: Executive - APICustom Field 2: 2869Location:Bavla, Gujarat, INCountry/Region: INState: GujaCity: BavlaCompany: Dishman Carbogen Amcis LimitedBusiness 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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