Purpose

To facilitate the preparation, review, and control of GMP documentation, thereby supporting regulatory compliance, product quality, and enhancing operational efficiency through effective document preparation, control, and management.

Position / Job Title

Officer

Department

Tech Transfer (Documentation)

Reporting To

Assistant Manager

Location

Pithampur (Madhya Pradesh)

Years Of Experience

3- 5Years

Dosage Form

Solid Orals

Job Responsibilities / Deliverables

Documentation & Protocol Preparation

Preparation and review of following documents

Batch Manufacturing Records (BMR)

Batch Packaging Records (BPR)

Intended batch BMR/BPR

Process Validation Protocols/Reports (PVP/PVR)

Hold Time Study Protocols/Reports (HTSP/HTSR)

Review and control of documentation to ensure consistency in manufacturing thereby reducing errors and deviations.

Drafting and maintain of master records.

To ensure the document for production & packing activities adhering to cGMP norms and right at first time.

Process Standardization

Review, and control documentation to ensure consistency in unit operations, thereby reducing errors and deviations.





Communicate with the QA/RA to obtain any documents or required information.

To ensure closing of validation reports in a timely manner.

Coordination & Cross-Functional Support

To co-ordinate Manufacturing, QA, QC, Warehouse, and Engineering to ensure smooth and timely preparation of documents and closing of document related change controls.

Ensure availability of all tech transfer documents prior to batch execution.

Change Control

Initiate, track, and ensure the timely closure of Change Controls related to document revisions.

Assist in the preparation of data and documents for regulatory submissions and audits.

Qualifications & Pre-requisites

B. Pharm / M. Pharm

Knowledge of unit operations involved in manufacturing and packing of solid oral dosage forms i.e. Granulation, Blending, Compression, Coating, Capsulation, Packing etc.

Basic knowledge of QMS/documentation (change control, document/Protocol/BMR/BPR preparation/review etc.)

Additional Notes

Role is expected to work in all shifts.

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