Details
Skills
SKILLS
• Strong business acumen connecting Operations, Quality, R&D, Innovation, Supply Chain, OE, Regulatory, Medical, and CMO management.
• In-depth understanding of regulatory requirements (submission documents) for OTC products in Australia, Asia, and the Middle East.
• End-to-end delivery of new product development (NPD) from concept to launch based on Quality by Design (QbD).
• Management of third-party manufacturing contractors (CMOs), both local and overseas.
• Project management for technical transfers of products based on QbD principles.
• Product risk assessments according to ICH Q8 and ICH Q9; trending and data management for Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).
• Experience with site remediations and upgrades including factory equipment validation and commissioning.
• Proficient in various pharmaceutical dosage forms: Oral Solid Dose, Elixirs, Suspensions, Effervescent, Respiratory, Semi-solids, and Naturals.
• Champion of continuous improvement and adept problem solver across international locations (Malaysia, Brazil, Costa Rica, Ireland).
About
PROFESSIONAL ACHIEVEMENTS
My achievements highlight my expertise in operational excellence, product development, product transfer, risk management, and cross-functional collaboration within the pharmaceutical industry
1. Operations Excellence Implementation: At Probiotec Pharma, I drove the introduction of Operations Excellence (OE) initiatives, resulting in a 30% improvement in waste through the implementation of 5S practices and a 50% reduction in line setup time.
2. New Product Development: As the New Product Development Manager at GSK, I was instrumental in launching innovative products such as "Voltanatra" and "Pananatra" in Australia, contributing to the company's expansion into alternative Cannabidiol (CBD) products for pain relief.
3. Technical Transfer Success: I successfully managed the technical transfer of 11 products valued at £30M from GSK to various Contract Manufacturing Organizations (CMOs) without any stockouts, demonstrating strong capability in project management and risk assessment. Approved CMC documents for submission within Australia, Middle East and Asia.
4. Continuous Improvement in Manufacturing: I led initiatives that resulted in a 50% reduction in repeat deviations by utilizing lean sigma tools to conduct operational investigations at GSK.
5. Robust Risk Management: Throughout his career with product transfers, I have implemented Technical Risk Assessments (TRA) and corrective actions that have minimized risks associated with product failures during transfers and commercialization.
6. Cross-Functional Collaboration: I have effectively collaborated with various teams across GSK and CMOs to ensure timely product launches and adherence to quality standards, contributing to zero impact on product supply continuity.
7. Management of technical testing laboratory for new products and existing products. Oversee Conduct all method development and method validation activities as per ICH and in-house guidelines.
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