System Validation Professional

1 week ago

Sydney, New South Wales, Australia beBeeValidation Full time $120,000 - $140,000

Ensuring the integrity and efficacy of advanced therapeutic systems is crucial in today's pharmaceutical landscape. As a seasoned Computer System Validation (CSV) Specialist, you will play a pivotal role in leading validation activities across GxP-regulated systems.

About the Role:

This full-time opportunity requires an individual with a strong background in CSV within GxP environments, possessing excellent analytical and problem-solving skills to drive high-quality results in a fast-paced setting.

Key Responsibilities Include:
  • Oversee IQ/OQ/PQ validation processes to ensure seamless integration of GxP systems.
  • Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and relevant regulatory frameworks.
  • Collaborate with IT, Quality Control, and business teams to deliver solutions that meet user and regulatory needs.
  • Author and review validation plans, risk assessments, and traceability matrices.
  • Contribute to data integrity programs and provide support during audits.
  • Develop training programs and promote a culture of quality excellence.
Requirements:
  • At least 3 years' experience in CSV within pharma, biotech, or medical devices.
  • Strong knowledge of GAMP 5, data integrity, and relevant regulatory requirements.
  • Experience validating ERP, LIMS, QMS, or equipment-related software.
  • Detail-oriented, analytical, and proactive team player.
  • Able to work flexibly to meet production schedules.

Why This Opportunity? You'll join a dynamic team driving innovation in therapeutic manufacturing, offering ample opportunities for growth and professional development.

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