Jun B. Email & Phone Number

Mississauga, Ontario, Canada

Actively participated in establishing new GMP facilities, led the development and implementation of a comprehensive quality system, encompassing policies, procedures and documentation. Developed and executed training programs to enhance quality awareness and ensure adherence to established quality standards. Proactively monitored and assessed compliance with GMP regulations, internal quality standards and industry best practice. Collaborated with regulatory agencies during inspections and audits, facilitating smooth process and ensuring compliance with regulatory requirements.

• Provide Quality Assurance & compliance support to Production, QC, Materials Management, Regulatory Affairs and other GMP functional areas to ensure compliance to regulations and policies.

Toronto, Ontario, Canada

• Perform routine qualitative and quantitative testing on incoming materials, packaging materials, finished products and marketed stability samples

Mississauga, Ontario, Canada

• Perform routine qualitative and quantitative testing on incoming materials, packaging materials, finished products and marketed stability samples

China

• Participate in establishing QC Lab in new facility. Prepare and revise SOP’s in QC operations. Manage document in pilot facility.• Awards for Quality Achievement 2000 & 2002

Bachelor Of Science - Bs, Fine Chemical Engineering

Graduate Certificate, Pharmaceutical Regulatory Affairs And Quality Operation