Assistant Manager

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.
• Review drug product analytical documentation 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 specifications proposals, test methods and Master formula cards for finished products.
• 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.
• Review and approval of Stability management activities of Drug substance and Drug products such as Stability Protocol, data and stability summary report.

Preferred candidate profile

• Masters (Pharmaceutical Chemistry / Quality Assurance / Analytical Chemistry / Organic Chemistry) with 10 - 14 years experience in reviews of Analytical method development & Validation from API & Formulations background.