
Shen Rong Qiu
SIGNIFICANT ACCOMPLISHMENT Accomplished ISO and GMP expert with 20+ years QA and RA experiences in pharmaceuticals and medical devices;... | Edmonton, Alberta, Canada
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Shen Rong Qiu’s Emails sh****@ya****.ca
Shen Rong Qiu’s Phone Numbers No phone number available.
Social Media
Shen Rong Qiu’s Location Edmonton, Alberta, Canada
Shen Rong Qiu’s Expertise SIGNIFICANT ACCOMPLISHMENT Accomplished ISO and GMP expert with 20+ years QA and RA experiences in pharmaceuticals and medical devices; Skilled at establishing and implementing quality management systems, such as ISO 9001, ISO 13485, QSR (21CFR 820), ISO14000, CGMP (21CFR 210 & 211) Experienced in managing global submissions to FDA, Health Canada, CE Marking and SFDA (China) CORE COMPETENCE Very strong ability to prioritize and handle multi-project assignments Excellent written and verbal communication skills Self- starter with strong attention to details and ability to work both independently and in a team Proficiency in Microsoft office (Word, Excel, PowerPoint, Visio) Specialties: Establish and Implement Quality Management Systems: ISO 9001, ISO13485, cGMP and QSR (21CFR 820). Regulatory Affairs in Medical Device and Pharmaceuticals including Global submission to FDA, Health Canada, CE Marking and SFDA and compliance program
Shen Rong Qiu’s Current Industry Genscript
Shen
Rong Qiu’s Prior Industry
Wuhan Blower Works Wuhan
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Rhk Group Co Ltd Wuhan
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Jinglun Electronic Co Ltd Wuhan
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Entreprise Importfab Inc Montreal
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Delon Laboratories Ltd Montreal
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Primed Medical Products Inc Edmonton
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Ken Block Consulting
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Gilead Sciences
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Evonik Vancouver Laboratories
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Kellyocg For Gilead Alberta Ulc
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Work Experience

Genscript
Sr. Director Quality
Wed Jun 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Kellyocg For Gilead Alberta Ulc
Sr. QA Manager (one year contract)
Mon Feb 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jun 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Evonik Vancouver Laboratories
Director Of Quality
Fri Mar 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri May 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Evonik Vancouver Laboratories
Assistant Director, Quality
Sat Dec 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Mar 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Gilead Sciences
Associate Director Quality Assurance
Thu Nov 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Nov 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Gilead Sciences
Senior Manager Quality Assurance
Sun Jan 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Oct 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Gilead Sciences
Manager QA
Mon Nov 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jan 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Ken Block Consulting
Senior FDA Medical Device Compliance Consultant (contract)
Thu Oct 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Oct 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time)
Primed Medical Products Inc Edmonton
Manager of Quality Assurance & Regulatory Affairs
Sun Oct 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Sep 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time)
Delon Laboratories Ltd Montreal
Quality Coordinator
Wed Sep 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Aug 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time)
Entreprise Importfab Inc Montreal
Production
Fri Aug 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Sep 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time)
Jinglun Electronic Co Ltd Wuhan
Quality Manager
Fri Jan 01 1999 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Apr 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time)
Rhk Group Co Ltd Wuhan
Quality Assurance Manager
Sat Feb 01 1997 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jan 01 1999 00:00:00 GMT+0000 (Coordinated Universal Time)
Wuhan Blower Works Wuhan
Mechanical Engineer
Fri Jul 01 1988 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 1996 00:00:00 GMT+0000 (Coordinated Universal Time)