Sumei Sun-KRB CONSULTING | Beijing KRB

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Name: Sumei Sun

Position: GMP Expert

Sumei Sun

GMP Expert

Background:

• First group of licensed pharmacist qualified in 1996

• Huabei Aventis, HISUN, Baxter, TSI technology – management of quality system, leading vaccine company - compliance consultant (since 2021)

• Extensive experience in quality management and production management of chemical and biological drugs

• Directly organized and led the FDA cGMP certification, EU GMP certification, WHO PQR certification, TGA GMP certification, China GMP certification, all successfully passed or obtained GMP certificate.

• Certification experiences of international quality audits for leading pharmas (Aventis, Pfizer, AstraZeneca, Merck, etc.) and GMP certification by NMPA.

Good at:

• Familiar with equipment qualification, sterilization/aseptic process validation, process validation and utility system validation for aseptic injectable production line, oral solid dosage form line, API production line

• Skilled in laboratory instrument calibration and analytical method validation

• Familiar with quality assurance and quality control systems, especially aseptic production systems

CONTACT

Phone number：400-0123-669

Address：A805, Tower A, Chaowai SOHO, 6B Chaowai Street, Chaoyang District, Beijing 100020