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Trainee Officer - Biotech

Trainee Officer - Biotech

Lupin

0 - 3 years

3 Lacs

Pune

Posted:1 day ago| Platform:

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Skills Required

Biotechnology Warehouse Risk assessment MFR GMP

Work Mode

Work from Office

Job Type

Full Time

Job Description

Visiting to DS manufacturing and warehouse facility to ensure that activities are being carried out by following GMP requirements, Regulatory requirement and as per approved procedures.
Line clearance for the process operation during manufacturing activity (Drug Substance).

Preparation and review the Risk Assessment and Mitigation Plan.
Ensure that process and cleaning validation activities are being carried out by following approved protocols.
Review of master document like study protocol, BPR, MFR etc

Review of executed Batch Processing Records for Batch Release.
Review of Batch Dispatch Record and verification of dispatch activities in warehouse.

Preparation and review of Quality System SOPs documents.
Review of SOPs as per GMP requirements for all departments.

Education

Masters in Biotechnology or Biotechnology

Competencies

1. Strategic Agility

2. Innovation Creativity

3. Customer Centricity

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