Amy Geng

Senior manager, Global Regulatory Compliance, APAC @ Johnson & Johnson

Country

China

City

Xuhui District

Industry

Biotechnology

Skill

QA, 人力资源, 项目管理, 战略规划, 研究, Microsoft PowerPoint, Microsoft Excel, Microsoft Word, FDA GMP, R 语言, SigmaPlot, Quality System, Quality Auditing, Good Manufacturing Practice (GMP), Data Analysis, Quality Management, Regulatory Affairs, Standard Operating Procedure (SOP), Clinical Research, Corrective and Preventive Action (CAPA)

Experience

Senior manager, Global Regulatory Compliance, APAC

Johnson & Johnson

2023-1 - Present · 3 yrs 9 mos

Shanghai, China

Senior QA Manager, Global GMP Quality

BeOne Medicines

2021-10 - 2023-1 · 1 yr 4 mos

中国上海市静安区

QA compliance manager, Global GMP Quality

BeOne Medicines

2020-5 - 2021-9 · 1 yr 5 mos

中国上海市上海市

-Lead and organize quality improvement plan to ensure that quality initiatives are executed and maintained in compliance with cGMP requirements -Lead and support the assessing quality gaps between the local BeiGene site SOPs and the Global standards. Take the responsibility in bringing and implementing solutions to these identities gaps. -Support Global Quality System and implementation of Global standards in China Provide -Coordinate and conduct qualification review and periodic re-assessment of suppliers in APAC -Support health authorities inspection and parter audit -Supplier management, audit and approval

QA Senior Manager

WuXi Chemistry

2018-4 - 2020-5 · 2 yrs 2 mos

Major CTM project QA operation management Commercial projects management Quality events investigation IND, NDA filling Stability study PPQ strategy PAR/NOR study Micriobial SME, DI( QC data audit trial) SME, production line SME, warehouse management SME, double blind project SME Environmental monitoring trending Major clients audit host, QP audit, HA audit.

Senior Associate Scientist

WuXi Chemistry

2016-11 - 2018-4 · 1 yr 6 mos

中国上海市

QA Specialist

上海联合赛尔生物工程有限公司

2012 - 2013-8 · 1 yr

上海

rhGH CFDA inspection Cholera vaccine CFDA audit Quality assurance management of Commercial vaccine and recombinant genetic product concentration, sterile filling and packaging. Commercial product quality trending, utility data trending. Equipment and facility Validation.

Training Development Supervisor

Hualan Biological Engineering Inc.

2008 - 2012 · 4 yrs

GMP training system establish. Training and performance assessment, human resources construction, manager evaluation. HA audit and government visit reception. Government public relations. H1N1 vaccine CFDA audit. H3N2 vaccine CFDA audit WHO pre-qualification ACYW135 vaccine CFDA audit HBVac CFDA audit