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上海, 临床及注册 | 2021-10-04

QA Senior Manager / Manager, Analytical

Job Title: QA Senior Manager / Manager, Analytical
Location: Shanghai

 

COMPETENCIES; Knowledge, Skills and Abilities

  • Must have a strong Quality Control mind-set with extensive knowledge and experience of cGMP operations as well as general industry (ICH, USP, etc.) and health authority (NMPA, FDA, EMA, PMDA, etc.) requirements for medicinal Drug Product.
  • Knowledge of risk management principles and their implementation into routine production and/or testing strategies.
  • Must be able to interpret problems and effectively communicate in a productive manner to management and teams.
  • Must be able to evaluate technical/scientific attributes and drive compliant technical decisions under minimal supervision.
  • Must have strong troubleshooting skills and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality requirements.
  • Must have strong hand-on solid dosage QC testing/operation experience that could immediately form a preliminary decision for an OOS that might trigger a Field Alert Report.
  • Must have strong experience of the OOS investigation.
  • Must have strong experience for the method validation and transfer
  • Must be fluent in both Chinese and English.

 

Duties and Responsibilities

  • Oversee and perform cross-functional QC laboratory assessments and implement improvements to assure Hutch-Med QC expectations would be fulfilled.
  • Collaborate with individual CMO QC team and individual cross functions (i.e. Analytical Development, Process, Formulation) to support strategies for improvement and implementation of best practices and automation.
  • Responsible for handling the analytical related issues like OOS result at CMO for commercial product in a timely manner and make a quick proposal to management team if marketed product is impacted.
  • In charge of the analytical method, specification, stability study, retain sample management for commercial products.
  • Lead the Product Quality/Analytical QA team to provide daily oversight on the good compliance of analytical document at Hutch-Med and its CMOs;
  • Provide product quality inputs to quality events, like product complaints.
  • Participate in the project CMC programing from analytical compliance perspective.
  • Develop product quality/analytical team members from both technical and soft skill perspective

 
Education and Experience

  • Bachelors’ degree in analytical chemistry and/or Pharmacy
  • Masters and above Degree preferred
  • Minimum of 7+ years of Pharma industry experience in a QC or QA role(s) supporting programs in pre-clinical phases through commercial, with at least two years management role
  • Strong project management skills and ability to communicate effectively across matrix functions
  • Excellent verbal and written English communication skills

 
If interested, please forward your resume to yvonnew@hutch-med.com