Executive

Job Description

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

• Documentation & Protocol Preparation
• Preparation and review of following document
• Batch Manufacturing Records (BMR)
• Batch Packaging Records (BPR)
• intended batch BMR/BPR.
• Process Validation Protocols/Reports (PVP/PVR)
• 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.
• 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.

• 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.
• 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
• 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.