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.
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.
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.
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.
