Purpose To facilitate GMP documentation preparing, review and enhancing operational efficiency through effective document preparation control and management.
Position/Job Title: Executive
Department MFG: (Documentation)
Reporting To: Assistant Manager
Location: Ambernath
Years of Experience: 5-8 Year
Dosage Form: Solid Orals or Nasal
Job Responsibilities/Deliverables
1. Documentation & Protocol Preparation
- Preparation and review of following document o Batch Manufacturing Records (BMR)
o Batch Packaging Records (BPR)
o intended batch BMR/BPR.
o Process Validation Protocols/Reports (PVP/PVR)
o Hold Time Study Protocols/Report (HTSP/HTSR)
- Review and control of documentation to ensure consistency in manufacturing thereby reducing errors and deviations.
- Drafting and maintenance of master records.
- To ensure the document for production & packing activities adhering to cGMP norms and right at first time.
2.
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 documents 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.
3.
Process
Standardization
- Review and control documentation to ensure consistency in unit operation, thereby reducing errors and deviations.
- Communicate with the client or the TT/RA to obtain any missing documents or required information.
- Ensure closing validation reports on time.
4. 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 control.
- Arrange all necessary documents prior to batch execution.
- Co-ordinate with QA and cross-functional team to review the document and ensure that BMR/Documents are available on the shop floor before starting production
5.
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,