QA Quality Systems

2 days ago

Tuas, Singapore WUXI XDC SINGAPORE PRIVATE LIMITED Full time $1,000,000 - $1,500,000 per year

Job Summary

Establish an effective quality management system and ensure it runs smoothly.

Responsibilities

  • Oversee the establishment and maintenance of an effective quality system, ensuring full compliance with the latest regulatory requirements.
  • Manage the entire GMP documentation lifecycle (creation/retired, revision, review, issuance, archiving and destruction), ensuring accuracy and control.
  • Be responsible for personnel training initiatives.
  • Oversee quality events management (deviation, CAPA, change control), ensuring all changes are thoroughly assessed before implementation.
  • Conduct regular reviews and assessments of quality metrics to ensure continuous improvement, including trend analysis of quality processes (deviation, CAPA, change control, complaints etc.).
  • Establish and implement a comprehensive Quality Risk Management Plan, ensuring timely execution and tracking mitigation efforts (if any) to completion.
  • Facilitate regular quality management review meetings in accordance with internal policies.
  • Take charge of regulatory surveillance and compliance, continuously monitoring regulatory changes, including but not limited to FDA, EMEA, PIC/S, cGMP, HSA and other relevant guidelines. Lead gap assessments and ensure timely implementation of necessary updates.
  • Lead internal audit program by developing audit plan.
  • Lead external audits and response to client / regulatory audits and coordinate CAPA implementation.
  • Oversee the supplier management program, including quality activities such as supplier qualification (audit and assessment), periodic performance monitoring, supplier change notification, decommissioning, establishing quality agreements to ensure compliance.
  • Handle product complaints efficiently.
  • Manage product recalls when necessary.
  • Perform other tasks assigned by leadership.

Qualifications

  • Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.
  • At least 8 years of working experience in production and/or quality management, with a minimum of 5 years in production QA, quality system QA or compliance QA.
  • Familiarity with FDA, EMEA, HSA and PIC/S GMP requirements.
  • Experience in setting up quality systems for new sites is preferred.
  • Experience in leading audits is preferred.
  • Experience with biopharma commercial quality systems is preferred.
  • Proficient in English listening, speaking, reading, and writing.
  • Skilled in Microsoft Word, Excel, PowerPoint, TrackWise, SAP etc.
  • Strong learning ability.
  • Effective at cross-functional communication and collaboration.

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