Singapore
I am a quality compliance professional with over 8 years of experience in pharmaceutical manufacturing, specializing in GxP compliance, risk-based auditing, and regulatory readiness. My background in chemical engineering, combined with certifications as a CQE, CQA, CMQ/OE and ISO 9001 Lead Auditor, enables me to strengthen quality systems and support right-first-time operations. Key highlights include: • Successfully supported a new biologics site launch and FDA pre-approval inspection with zero observations. • Led risk-based audit process improvements to sharpen compliance focus. • Oversaw production capacity scale-up projects while maintaining strict regulatory standards. I am passionate about embedding a culture of quality ownership across teams and ensuring products meet the highest standards of safety and efficacy.
-Built and managed core OSP-2 QA systems during plant startup; covering logbooks, product reviews, deviations, CAPA, complaints, and authority delegation, supporting site-wide compliance. -Drove inspection readiness and GMP compliance by leading the internal audit program, developing risk-based strategies, and serving as lead auditor. -Strengthened regulatory support for APIs including Tofacitinib, Palbociclib, and Tafamidis through change control assessments, global submissions, and CTD reviews. -Advanced quality risk management by deploying global QRM processes (maturity assessment, master plan, Quality Risk Register) as site Local Process Owner, and leading periodic risk reviews and mitigation planning. -Led material qualification for critical raw materials, ensuring supply chain reliability and operational readiness for production. -Directed the site-wide deployment of global inspection management software, standardizing audit preparation and improving inspection response efficiency. -Built organizational capability by mentoring junior staff, training auditors, and serving as a certified trainer for site-wide GMP programs.
-Ensured compliant batch execution during Venetoclax and Atogepant API campaigns through rigorous review of batch and cleaning records, incoming materials, and plant walk-downs. -Managed 40+ change plans, including major technology transfer projects, reinforcing robust change management across the site. -Enhanced data integrity and efficiency by improving the maintenance work order review workflow and providing quality oversight in tier meetings. -Supported timely resolution of nonconformances through cross-functional investigations of quality issues. -Drove quality performance improvements in multi-product manufacturing by leading the Right First Time initiative, using biweekly reviews and data analysis to reduce errors.
-Strengthened regulatory readiness by managing 20+ internal and external audits and implementing a risk-based internal audit strategy. -Enhanced team capability through auditor training programs and site-wide compliance culture initiatives. -Improved audit and compliance processes by automating commitment tracking (achieving 100% on-time compliance). -Boosted operational performance by coordinating change controls relating to production scale-up of Humira (65 → 80 batches annually) and supporting validation, submissions, and engineering initiatives. -Facilitated regular change review board meetings. -Increased organizational preparedness through three mock recalls, improved cross-functional coordination, and nuisance alarm reduction projects.
-Provided quality oversight during Project Genesis, supporting site qualification, validation activities, and the successful commercial launch of Humira. -Contributed to an FDA pre-approval inspection that concluded with zero 483 observations, ensuring smooth product registration and supply readiness.
-Ensured ISO 9001 compliance through internal audits and CAPA management. -Supported customer and external audits, addressing findings and driving sustainable corrective actions. -Partnered with production teams to improve process controls via regular Statistical Process Control review meetings, reducing non-conformities and enhancing product reliability. -Facilitated root cause investigations and implemented preventive measures to strengthen operational consistency. -Oversaw acceptance sampling program for final product to ensure release of conforming product.