Executive

Job Description

Purpose - To be Responsible for the effective and compliant transfer of new products from R&D/Formulation & Development (F&D) to the manufacturing plant, ensuring readiness of materials, processes, documentation, equipment, analytical requirements, and manufacturing activities in accordance with GMP and company procedures

Position / Job Title - Sr. Officer/Executive

Department - Technology Transfer

Reporting To - GM- Tech transfer

Location - Pithampur (Madhya Pradesh)

Years of Experience - 3-5 Years

Dosage Form - Solid Orals

Job Responsibilities / Deliverables

• Documentation
  
  

Preparation of Raw material and packing material BOM

Category creation in SAMWED for all relevant documents required for scaleup, exhibit and validation batch.

Review product development documents, manufacturing process, specifications, packaging requirements, and technical information received from F&D.

Prepare and maintain RM/PM requirement and tracking plans, ensuring materials are available as per project timelines.

Prepare and review technology transfer protocols, checklists, manufacturing instructions, process flow documents, and other technical transfer documentation.

• Ensure transfer of critical process parameters (CPPs), critical quality attributes (CQAs), process controls, and manufacturing precautions from F&D to Production.
• Batch Execution monitoring
  
  

Perform scale-up calculations for formulation, batch size, material quantities, process yields, equipment capacity, processing parameters and other manufacturing requirements.

Coordinate and monitor scale-up, exhibit, and process validation batches at the manufacturing site for critical unit operations.

Review batch execution data, manufacturing observations, yields, process times, equipment performance and process deviations to identify gaps between laboratory/development scale and commercial manufacturing scale.

Identify process challenges during execution and coordinate with concerned departments for resolution.

• Coordination & Cross-Functional Support
  
  

Coordinate with F&D, Production, QA/QC and Engineering for investigation and resolution of process deviations, yield issues and technical problems encountered during batch execution.

Act as a center point of contact between R&D, Product Development, Manufacturing, QA, QC, Warehouse, and Engineering for smooth and timely execution of batches.

Provide technical recommendations for process optimization, productivity improvement, yield improvement and robust commercial-scale manufacturing.

• Quality management system
  
  

Initiate, coordinate and technically support Change Controls related to product, process, equipment, materials, specifications, documents and manufacturing site requirements.

Participate in investigation of OOS, OOT, deviations, process failures, yield discrepancies and other quality events associated with products under technology transfer/manufacturing.

Support preparation and review of risk assessments, CAPA, effectiveness checks and other QMS documentation.

• Regulatory & Technical Support
  
  

Provide technical support for regulatory queries received from regulatory agencies/customers related to manufacturing process, technology transfer, scale-up, batch records, process parameters, deviations, validation and product performance.

Coordinate with F&D, QA, QC, Production and Regulatory Affairs for data collection, technical assessment and preparation of responses to regulatory queries.

Qualifications & Pre-Requisites

M Pharm (Pharmaceutics)

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

Basic knowledge of QMS (change control, deviation etc.)

Additional notes - Role is expected to work in all shifts.