Specialist 2, Qa (validation And Technical Compliance)

Lonza Group

Singapore
Competitive compensation programs; comprehensive m...
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Bachelor's degree in quality assurance
Significant experience in biopharmaceutical industry
Knowledge of fda, ema, and ich guidelines
** Lonza Group is seeking a QA Specialist to support Quality Assurance activities in a cGMP contract manufacturing facility in Singapore. The ideal candidate will have a Bachelor's degree and significant experience in Quality Assurance within the biopharmaceutical industry, with knowledge of regulatory requirements and quality management systems. **

Job Summary

  • The role provides QA oversight for QC/DS lab services including the review and approval of protocols, reports, deviations, and CAPA implementation.
  • Candidates must apply Root Cause Analysis tools to ensure effective closure of quality records and oversee Quality Change Requests.
  • The company offers an agile career with competitive compensation, comprehensive medical insurance, and company transport from designated MRT locations.

Matching Summary

Match Score: 75

** Lonza Group is seeking a QA Specialist to support Quality Assurance activities in a cGMP contract manufacturing facility in Singapore. The ideal candidate will have a Bachelor's degree and significant experience in Quality Assurance within the biopharmaceutical industry, with knowledge of regulatory requirements and quality management systems. **

Salary

Competitive compensation programs; Comprehensive medical insurance; Company transport provided

Skills & Requirements

Must-have

  • Bachelor's degree in Quality Assurance
  • Significant experience in Biopharmaceutical industry
  • Knowledge of FDA, EMA, and ICH guidelines
  • Root Cause Analysis tools application
  • GMP facility quality management system

Nice-to-have

  • Qualified Trainer capability development
  • Cross-functional project leadership
  • Global exposure opportunities
  • Strong stakeholder relationship building
  • Inclusive and ethical workplace values

Key Requirements

  • Bachelor's degree required
  • Significant years' experience in Biopharmaceutical QA
  • Familiarity with FDA, EMA, and ICH regulations

Work Rights

Not specified

Tailored Resume

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