Salary Range
SGD 54,000 - SGD 108,000 /year
SGD 4,500 - SGD 9,000/month
Skills Required
GxPPharmaceutical IndustryMaster Planningtraining proceduresRisk assessment, insurancecGMP ManufacturingRegulatory Compliancevalidation documentationGMPCross-functional CoordinationExecute validation protocolsSystems ComplianceComputer System Validationc-GMP
Job Description
Responsibilities
- Develop and implement strategies for the validation of computer systems in compliance with domestic and international regulations.
- Prepare and maintain all necessary validation documents, including validation master plans, validation plans, and risk assessments.
- Execute validation protocols and prepare validation summary reports.
- Manage change control for validated systems and perform impact assessments for changes to validated systems.
- Conduct training on CSV principles and procedures.
- Ensure compliance with all relevant regulations, including GxP, GAMP5, ERES, and Data Integrity.
- Collaborate with cross-functional teams to ensure smooth execution of validation activities.
Requirements
- Experience in a CSV role within the pharmaceutical industry is a MUST.
- Strong knowledge of GMP, GAMP5, ERES, and Data Integrity
About ITCAN PTE. LIMITED
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