Validation QA Specialist

2 days ago

Tuas, Singapore WuXi AppTec Singapore Pte. Ltd. Full time $80,000 - $120,000 per year

Job Description:

Responsible for managing validation activities related to equipment, warehouse facilities, cleaning, water systems, and utility gases, ensuring that the production environment and critical systems comply with GMP and relevant regulatory requirements, thereby guaranteeing product quality and production safety.

Key Responsibilities:

  • Develop and draft validation plans, protocols, and related documents for equipment, warehouse facilities, cleaning, water systems, and utility gases.
  • Review validation protocols, reports, and related technical documents to ensure compliance with company standards and regulatory requirements.
  • Track and supervise the execution of validation activities, coordinating with relevant departments to ensure smooth completion.
  • Organize and participate in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of equipment.
  • Design and execute cleaning validation protocols, ensuring the effectiveness and reproducibility of cleaning procedures.
  • Participate in validation of water systems and utility gases, ensuring systems meet design specifications and usage standards.
  • Responsible for Computerized System Validation (CSV), including validation planning, risk assessment, test script design, and execution, ensuring compliance with GAMP5 and relevant regulations.
  • Review monitoring data and periodic monitoring reports of cleanrooms and purified water systems.
  • Handle system-related changes and deviations, driving investigations and implementation of corrective and preventive actions (CAPA).
  • Support customer audits by preparing audit documentation and cooperating throughout the audit process.

Qualifications:

  • Bachelor's degree or above in Pharmacy, Chemistry, Mechanical Engineering, or related disciplines.
  • 1-3 years of experience in validation QA within the pharmaceutical industry.
  • Familiar with GMP, FDA, EU GMP regulations, and validation standards.
  • Proficient in validation processes and requirements for equipment, warehouse facilities, cleaning, water systems, and utility gases.
  • Familiar with Computerized System Validation (CSV) processes and GAMP5 guidelines.
  • Capable of drafting validation plans, protocols, and reports; proficient in Microsoft Office applications.
  • Strong communication and coordination skills, team-oriented, with a strong sense of responsibility.
  • Fluent in both Chinese and English, capable of reading and drafting validation-related documents.

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