Senior QA Specialist

5 days ago

Tuas West Region, Singapore WuXi XDC Full time $104,000 - $130,878 per year

Job Summary

Responsible for overseeing QC testing, validation and warehousing activities, ensuring compliance with internal procedures and regulatory requirements.

Responsibilities

  • Oversee routine quality control for on-site GMP production and testing, ensuring all GMP activities are executed in strict adherence to company procedures.
  • Contribute to the establishment of an effective quality system and ensure its efficient operation across all GMP functions and processes in daily operations.
  • Provide quality oversight for validation and re-qualification engineering activities, ensuring validation status is consistently maintained.
  • Provide quality oversight for warehouse functions to ensure compliance
  • Review and approve GMP manufacturing and testing-related documents.
  • Authorize the release of facilities, utilities, equipment, and instruments for production use.
  • Manage quality events, including deviations, change controls, CAPA, and lab investigations etc.
  • Support both internal and external audits.
  • Carry out additional tasks as assigned by leadership.

Qualifications

  • Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.
  • At least 8-10 years of relevant QA experience in Biopharma or Pharmaceuticals industry
  • Familiar with FDA, EMEA, and PICS GMP requirements.
  • Knowledgeable in biological product manufacturing and related quality control requirements.
  • Experience with a new site start-up is preferred.
  • ADC manufacturing and quality management experience is a plus.
  • Proficient in English listening, speaking, reading, and writing.
  • Skilled in Microsoft Word, Excel, PowerPoint, etc.
  • Strong learning ability.
  • Excellent cross-functional communication and collaboration skills.
  • Strong logical thinking and conflict management abilities.
  • Demonstrates strong ownership.

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