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Hetero Labs Limited
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Assistant Manager

Assistant Manager

Hetero Labs Limited

9 - 11 years

3 - 12 Lacs

hyderabad telangana india

Posted:16 hours ago| Platform: Foundit logo

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Skills Required

regulatory dossier preparation product registration ich guidelines asia regulatory requirements lifecycle management

Work Mode

On-site

Job Type

Full Time

Job Description

Documentation & SOP Management

Prepare and implement standard operating procedures, batch manufacturing records, protocols, cleaning procedures, and log sheets.
Maintain all documentation in compliance with cGMP and regulatory requirements.
Ensure timely review and revision of SOPs related to FP departments.

Quality & Compliance Activities

Handle QMS activities including change controls, deviations, incidents, and risk assessments.
Perform DQ, IQ, OQ, and PQ qualifications for equipment.
Support in audit preparedness and ensure all documentation is audit-ready.

Training & Team Management

Ensure departmental employees are trained as per the TRIMS training schedule.
Attend and ensure participation in all relevant training programs, including cGMP and equipment-specific SOPs.

Production & Execution

Execute formulation and aseptic filling activities in line with the production plan.
Lead simulation trials like media fills and ensure compliance in aseptic processing areas.
Achieve planned FP targets while strictly adhering to cGMP guidelines.

Equipment Maintenance & Coordination

Coordinate with Engineering and QA for execution of preventive maintenance plans.
Monitor equipment performance and initiate necessary actions to ensure uninterrupted operations.

Reporting & Communication

Perform daily operations as per schedule and report all activities, deviations, and issues to the reporting officer promptly.
Maintain logbooks and ensure batch documentation is updated in real-time.

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