||QA Senior Manager / Manager, Analytical
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 email@example.com