To liaise with internal clients including Innovation & Development, Technical Services, regulatory & Corporate Affairs, Quality Assurance/ Quality Control and Material/ procurement departments and sometimes jointly meeting with external clients, including raw material vendors for activities relevant to new product development (NPD).
To support Regulatory Affairs in dossier preparation for new products and reformulation projects.
To work as an effective member in the I&D Technical Team consisting of pharmacists, chemists and other disciplines.
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To support in complaints and product recall investigations, establish oversight and governance process upon complaint receipt and trigger of the product recall throughout till closure of the complaint and recall.
To perform failure investigation (Deviation) and propose quality CAPA, establish system with well-defined roles and responsibility of cross functional team, process if investigation inclusive timeline, quality of root cause analysis, quality of proposed CAPA, effectiveness check upon closure etc, to avoid recurrence of similar root cause.
To investigate the potential root causes on out of trend and out of specification issue in product stability studies program and finished product analysis, where priority on patient safety would be addressed and appropriate preventive actions are implemented with closely monitoring and documented.
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Finished Good Return Management: Manage the process of returned finished products including evaluation, investigation, and final disposition. Maintain documentation of returned goods in accordance with GMP and company procedures.
To ensure real-time monitoring, verification and control of manufacturing and packaging processes in compliance with Good Manufacturing Practice (GMP), company SOPs, regulatory standards and ALCOA+ compliance.
To perform investigation related to IPQA testing out-of-specification.
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Compliance – Comprises of Comparative Dissolution Profiling (CDP), Photostability and Stability Study (SS), In-Use Stability Study (IUSS), Maintenance of Analytical Method Lifecycle, Quality Control (QC) of Starting Materials and Certificate of Analysis Generation for Investigational Medicinal Product (IMP).
Laboratory Operations – Comprises of Document Management, Digital Enabled Laboratory Project, Consumables Management and Maintenance of Good Laboratory Practice, Personnel Qualification, and Equipment Lifecycle.
To lead analytical method development & validation for new raw material, packaging and product (NPD) for both in-house developed or technical transfer, reformulation, and cleaning validation.
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Develop and grow the targeted specialists’ accounts in the private sector.
Build and established a healthy business relationship with targeted specialists and medical officers in the government institutes (government Hospitals and polyclinics) to increase the prescription of the tender products.
To list in CHC products into the retail pharmacies in the government institutes which includes the polyclinics’ pharmacies.
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