ASSOCIATE DIRECTOR

Company Overview

Role Purpose

Academic Stream

Work experience (in months)

Job Responsibility and key Decisions

Handling of all IPQA related activities facility GMP compliance.

Review of master executed batch records and checklists.

Review of study protocols, process validation, cleaning validation etc protocols and reports.

Review of TTDs cell bank, inoculum and downstream.

Review of change control related to cell bank, inoculum and downstream.

Responsible for review of investigation reports pertaining to downstream deviations.

Responsible for ensuring processfacility related CAPA implementation and verification of CAPA effectiveness.

Responsible for supporting regulatory with required documents for filings.

Review and preparation of sitespecific QA SOPs.

Review of production SOPs.

Ensure audit readiness, shop floor oversight and GMP compliance, support in audit preparation, handling, and observation closure.

Review of CPV parameters from production, QC and control systems, and data trends

QA connect for new product initiation in DS manufacturing facility and cross functional requirement.