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Manager, Technical Transfer at Amneal India

, , India -

Full Time

Start Date

Immediate

Expiry Date

14 Jun, 26

Salary

0.0

Posted On

16 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Scale-Up Monitoring, Exhibit Batch Execution, Validation Batch Monitoring, Document Review, Procurement Coordination, Tooling Procurement, RM Code Creation, Process Validation, Batch Manufacturing Records Review, Stability Studies, Change Controls, Deviation Management, CAPA, Investigations, Process Improvement, Cycle Time Reduction

Industry

Pharmaceutical Manufacturing

Description

Job Responsibility * To monitor scale up batches, exhibit batches, pre-validation batches & validation batches as per approved plan, and check/review/approve related documents. * To co-ordinate for procurement of tooling, RM code creation, RM indent for site transfer projects & new products. * To execute exhibit batches with alternate API source. * To execute & monitor activity related to product site transfer projects & relevant documentation. * To monitor critical process parameters of process validation batches of new/existing products & related documentation, ensuring successful launch of new products. * To review batch manufacturing records (proposed & commercial), process study protocols & reports, trial batch protocols & reports. * To review stability protocols, validation protocol, change controls, deviation, CAPA, investigations & other relevant documents. * To support documentation, process validation, troubleshooting, process improvement & cycle time reduction activities in scale up, exhibit & validation batches. Skills: * Expertise in monitoring scale-up, exhibit, and validation batches. * Strong in reviewing BMRs, protocols, reports, stability studies, deviations, CAPA, and change controls. * Effective coordination with R&D, QA/QC, Regulatory, and Manufacturing teams. * Hands-on problem solving, process improvement, and cycle time reduction. * Strong understanding of regulatory guidelines for OSD

Responsibilities

The manager will monitor various production batches, including scale-up, exhibit, pre-validation, and validation batches, while reviewing and approving all associated documentation. Responsibilities also include coordinating procurement activities, executing site transfer projects, and monitoring critical process parameters for successful product launches.