Assistant Manager - Development Quality Assurance

Role & responsibilities

• Prepare Revise and Peer Review Standard Operating Procedures and Guidelines for DQA.
• Responsible for review of analytical documents from early & late-stage development, technology transfers to CMOs sites of API and Formulations.
• Review drug products/Drug Substance analytical documents such as protocols, SOPs, test methods, data, ROAs, COAs and reports through collaboration with ARD and QC scientists, to achieve the highest quality from technical and compliance perspectives.
• Review pre-formulation development documents of analytical method development/validation reports, stability protocols & reports, and pre-formulation studies.
• Review data for API and Drug Product specification proposals, test methods and Master formula cards.
• Responsible for investigations against laboratory Incidents, OOS, OOT encountered with aim of root cause identification and CAPA implementation.
• Responsible for assessing the impact, review and closure of Change control requests and Deviations.
• Responsible for CAPA implementations, verification of and effectiveness.
• Responsible for maintaining the Quality Metrics and preparation of Quality Metrics.
• Plan, execute internal audits and communicate audit schedules, outcomes to audit stakeholders ensuring CAPA appropriateness for closer, audit trending for continual quality improvement.

Preferred candidate profile

Masters (Pharmaceutical Chemistry / Quality Assurance / Analytical Chemistry / Organic Chemistry) with 10 - 14 years DQA experience from API industry