Job Description

Purpose To facilitate GMP documentation reparation, review and enhancing operational

efficiency through effective document preparation, control and management.

Position / Job Title Officer - Department MFG (Documentation)

Reporting To - Assistant Manager

Location - Ambernath

Years of Experience - 2-4 Years

Dosage Form - Solid Orals and / or Nasal

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.

Operation Efficiency

Streamline documentation workflows to improve productivity, traceability, and

accountability across departments.

Submit BMR requests to QA and ensure that BMRs are available on the shop

floor before starting production.

Provide suggestions with respect to document for improving productivity, safety,

and cost efficiency.

Monitor and control the manufacturing process with respect to documentation for

each optimization, validation, and commercial batch, incorporating provided

technical inputs and implementing document changes as and when required.

Process Standardization

Review, and control documentation to ensure consistency in unit operations,

thereby reducing errors and deviations.

Communicate with the TT/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 execution of documents and closing of document revision change controls.

Arrange all necessary documents prior to batch execution..

Co-ordinate with QA and cross functional team to review the documents and

ensure that BMRs/Documents are available on the shop floor before starting

production.

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. and nasal operations.

Basic knowledge of QMS/documentation (change control,

document/Protocol/BMR/BPR preparation/review etc.)

Additional notes

Role is expected to work in all shifts.