Team Member--MSAT- Product Group- R & D Quality

Company Overview

Role Purpose

Academic Stream

Work experience (in months)

Job Responsibility and key Decisions

Process Development Support

Perform handson execution of experiments and scaleup trials.

Support optimization of formulations and processes based on data analysis and crossfunctional inputs.

Technology Transfer

Prepare and compile documents e.g., BMRs, PFDs, SOPs required for transferring processes to manufacturing sites.

Assist in training manufacturing personnel and participating in tech transfer execution at plant level.

Process Validation Support

Support preparation and execution of process validation activities, including sampling, inprocess testing, and data recording.

Assist in preparation of validation protocols and summary reports.

Quality Integration

Ensure GxP compliance during execution of all activities.

Document deviations, support investigations, and contribute to CAPA implementation under supervision.

Documentation Reporting

Draft and maintain accurate experimental records, development reports, risk assessments, and batch execution data.

Contribute to regulatory documentation by providing supporting technical data or reports.

CrossFunctional Support

Participate in project team meetings to provide updates on experimental progress and technical issues.

Collaborate with formulation, analytical, QA, and regulatory teams to ensure endtoend quality integration.

Identifying and escalating any deviations, process risks, or equipment issues.

Recommending minor procedural or process improvements based on experimental findings in consultation with leads.

Selecting appropriate sampling plans or test methods in line with protocols.

Support the documentation and processing of CAPAs, deviations, and change controls within the MSAT product group.

Assist in preparing and maintaining QMS records and reports.

Help coordinate responses to internal audits and regulatory inspections.

Support root cause investigations by gathering data and documentation.

Maintain compliance with GMP and internal quality policies in all QMS activities.

Collaborate with Quality Assurance and other functions to resolve qualityrelated issues.

Participate in quality improvement initiatives as assigned.

Key Decisions

Identify and escalate quality issues or documentation gaps promptly.

Decide when to seek guidance from supervisors or Quality Assurance.

Recommend minor updates or corrections to documentation for review.

Ensure timely completion of assigned QMS tasks.