About this role
1. Job Purpose
To support Development Quality Assurance activities for CSBU-R&D by ensuring compliance with applicable GMP, quality systems, regulatory requirements, and internal procedures across pharmaceutical development activities. The role involves review, monitoring, documentation, deviation management, and quality oversight of R&D processes to ensure products are developed in accordance with defined quality standards.
2. Key Responsibilities
A. Quality Assurance & Compliance
* Ensure compliance with applicable GMP, GLP, regulatory guidelines, and internal quality systems.
* Provide QA oversight for pharmaceutical development activities and associated documentation.
* Review and approve/recommend approval of R&D documents as per defined procedures and authorization matrix.
* Ensure adherence to SOPs, policies, specifications, protocols, and established quality standards.
* Support implementation and continuous improvement of quality systems within CSBU-R&D.
B. Documentation & Data Review
* Review development protocols, reports, specifications, analytical documents, batch records, and other quality-related documents.
* Ensure documentation is complete, accurate, traceable, and compliant with ALCOA+ principles.
* Review laboratory and development data for completeness and integrity.
* Maintain appropriate quality records and ensure timely closure of documentation activities.
C. Deviation, CAPA & Change Control
* Support investigation and review of deviations, incidents, OOS/OOT and other quality events.
* Participate in root-cause analysis and evaluation of CAPA effectiveness.
* Review and monitor change controls impacting R&D activities.
* Ensure timely implementation and closure of assigned CAPA and quality actions.
D. Audits & Inspection Readiness
* Support internal audits, self-inspections, customer audits, and regulatory inspections.
* Coordinate with R&D stakeholders to ensure timely closure of audit observations.
* Monitor compliance gaps and support preparation of appropriate action plans.
* Ensure continuous inspection readiness within the assigned R&D functions.
E. Quality Risk Management
* Participate in quality risk assessments related to development activities.
* Identify potential quality and compliance risks and recommend appropriate controls.
* Support implementation of risk-based quality management practices.
F. Training & Quality Culture
* Support identification of GMP and quality training requirements for R&D employees.
* Conduct/coordinate quality-related awareness and training programs.
Promote a strong quality culture and compliance mindset across R&D teams.