Shu Yi Loh

• Registered Pharmacist and Responsible Person (RP) for Lotus International - Therapeutic Product Import and Wholesale License.
• As a Responsible Person, successfully hosted and completed 2 HSA regulatory audits with zero findings.
• Manage 60 suppliers / contract manufacturing organizations (CMO) in across Europe and APAC for finished products, semi-finished products and Active Pharmaceutical Ingredients (API) that are traded through Lotus International business entity to Lotus Affiliates in South Korea, Taiwan and South- East Asia (SEA) markets .
• Co-ordinate and ensure that suppliers/ CMOs audits are performed timely by the Global Audit team for new and routine audits.
• Manage 20 distributors in Hong Kong, Philippines, Thailand, Vietnam, Malaysia, Indonesia, Bangladesh, Sri Lanka and Singapore.
• Conduct new and routine GDP audits for responsible distributors. Successfully conducted 9 audits in Singapore, Malaysia, Philippines and Vietnam.
• Establish and maintain a Quality Management System. Successfully established 21 procedures for SEA markets.
• Responsible for the learning and training management for SEA markets.
• Manage Quality Technical Agreement (QTA) with contract manufacturers/suppliers and distributors before new product launch for Lotus International and affiliates.
• Responsible to release in-bound shipments for finished products, semi-finished products and APIs for Lotus International and affiliates.
• Responsible for intake of complaints and review of complaint investigation report for countries of responsibility.
• Responsible for the review of PQR in accordance with the Lotus International policies.
• Review and approve for master data creation in SAP.
• Assist in Pharmacovigilance reporting and risk management plans.

• Serve as the Management Representative (MR) with the responsibility and authority to, maintain an effective the Quality Management System (QMS), report to top management on the its effectiveness at planned management review meetings.
• Responsible for communication with HSA on regulatory matters and medical device software related discussions.
• Manage the quality aspects in the medical device software Design Control process.
• Part of the core team for the development of the medical device software.
• Responsible for management of suppliers including qualification and monitoring.
• Plan, schedule, host and conduct internal quality audits, to create audit reports, follow up on CAPAs for audit closure in order to assess compliance with company and regulatory requirements.
• Host external audits by Notified Bodies and regulatory agencies and to follow up on CAPAs for audit closure.

Regulatory Oversight

• Holds site regulatory permit, license, certification for pharmaceutical products and medical devices
• Assist in customer and internal regulatory related enquires
• Provide quality/regulatory changes or issues during management review in operation meeting

Quality Assurance Oversight

• Maintain Quality Management System
• Manage product disposition and release for incoming shipments and redressed products.
• Participate and facilitate internal and external (customer & regulatory) audit
• Manage supplier qualification and monitor performance
• Responsible for calibration schedule for warehouse equipment and temperature sensors.

• Responsible for Clinical Trial operations
• Responsible for Investigational Product inventory and records

• Ensure cleanroom meets ISO standards and lab equipment are routinely calibrated and maintained.
• Supervise 6 pharmacy technicians in their daily routines such as preparing sterile products and extemporaneous preparations.
• Maintain inventory of pharmaceutical supplies and consumables
• Set up Home Parenteral Nutrition service
• Work in a multi-disciplinary team in Gastroenterology and Nutrition rounds to provide care for pediatric and neonatal, high dependency, surgical and oncology patients
• Evaluate new drugs to be added into formulary and present to the Pharmacy & Therapeutics committee (Literature review)