CSV Engineer

Company

PSC Biotech Corporation

Location

Singapore, Singapore

Type

Contract

Job Description
Develop and review validation plans, protocols (IQ, OQ, PQ), and reports for computerized systems.
Perform risk assessments and impact analysis related to system validation.
Ensure compliance with regulatory guidelines such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
Collaborate with IT, Quality Assurance, and Manufacturing teams to support system qualification and validation activities.
Manage change control and deviation investigations related to validated systems.
Support audits and inspections by regulatory authorities.
Maintain validation documentation and ensure traceability throughout the system lifecycle.

Requirements
Bachelor’s degree in Pharmacy, Life Sciences, Engineering, Computer Science, or related field.
5-8 years of experience in CSV within pharmaceutical manufacturing or related regulated industries.
Strong knowledge of GxP regul...
        

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CSV Engineer

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