Computer System Validation

1 week ago


Singapore SANTECH ENGINEERING PTE. LTD. Full time

Key Responsibilities: Develop and review validation plans, protocols (IQ, OQ,PQ), and reports for computerized systems. Perform risk assessments and impact analysis related tosystem validation. Ensure compliance with regulatory guidelines such asFDA 21 CFR Part 11, EU Annex 11, and GAMP 5. Collaborate with IT, Quality Assurance, andManufacturing teams to support system qualification and validationactivities. Manage change control and deviation investigationsrelated to validated systems. Support audits and inspections by regulatoryauthorities. Maintain validation documentation and ensuretraceability throughout the system lifecycle. Qualifications: Bachelor's degree in Pharmacy, Life Sciences,Engineering, Computer Science, or related field. 5-8 years of experience in CSV within pharmaceuticalmanufacturing or related regulated industries. Strong knowledge of GxP regulations, 21 CFR Part 11,Annex 11, and GAMP 5 guidelines. Experience with validation of PLC SCADA, MES, or otherpharma manufacturing Automation systems. Excellent documentation and communication skills. Ability to work independently and in cross-functionalteams. #J-18808-Ljbffr



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