Role Overview:
We are seeking a Junior CSV Engineer to join Anter to support Computer System Validation (CSV) activities for pharmaceutical clients in Singapore. The role involves assisting with validation execution, documentation, and compliance to ensure systems meet regulatory and quality standards.
Key Responsibilities:
Assist in the preparation, execution, and review of IQ/OQ/PQ protocols.
Support CSV documentation, including validation plans, traceability matrices, and reports.
Collaborate with cross-functional teams (QA, IT, Operations) to ensure system compliance.
Participate in testing, verification, and data review for validated systems.
Assist in audit readiness and regulatory compliance activities.
Qualifications & Experience:
Bachelor's degree in Engineering, Life Sciences, or related discipline.
1-3 years' experience in pharmaceutical CSV or Validation preferred.
Understanding of GxP regulations, 21 CFR Part 11, and EU Annex 11.
* Good communication and teamwork skills; detail-oriented and proactive.
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