CSV Validation Engineer

Roles & Responsibilities Responsibilities: Work with a cross functional team in providing Quality oversight in computerized system life cycle procedure and ensure compliance to GXP standards and company policies and procedures. As the Subject Matter Expert (SME) in CSV topics, provide guidance and support to establish systems for ensuring Data...

Roles & ResponsibilitiesResponsibilities:Work with a cross functional team in providing Quality oversight in computerized system life cycle procedure and ensure compliance to GXP standards and company policies and procedures. As the Subject Matter Expert (SME) in CSV topics, provide guidance and support to establish systems for ensuring Data integrity,...

At Coalesce Management Consulting, we are a community of people with a strong passion for excellence. We deliver bespoke project solutions within the Life Science and Technology sectors through our community of high-calibre industry specialists. **Position: CSV Engineer** We are currently expanding our team and are looking for a **CSV Engineer**to support...

As a CSV Engineer, you will be working for our clients in the respect of the applicable regulations and quality procedures. Main assignments: - To be responsible for preparing and/or executing validation activities and documentation for Computerized Systems, under respected regulations or guidelines: 21 CFR Part 11, 21 CFR Part 820, ISO 13485, GAMP 5,...

**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. -...

**Responsibilities**: - Work with a cross functional team in providing Quality oversight in computerized system life cycle procedure and ensure compliance to GXP standards and company policies and procedures. - As the Subject Matter Expert (SME) in CSV topics, provide guidance and support to establish systems for ensuring Data integrity, compliance to CSV...

Roles & ResponsibilitiesResponsibilities:Manage Computer System Validation Lifecycle from design to execution phases, Including relevant CSV documentations such as Configuration specification, design review, commissioning documents, and protocols. Work with QA and stakeholders to develop the CSV strategy Responsible for providing CSV documents and...

Roles & Responsibilities We are seeking a Computer System Validation (CSV) Engineer with around 5 years of relevant experience to support QC and laboratory operations in a regulated GMP environment. The role involves ensuring that computerized systems and laboratory equipment are validated, maintained, and compliant with regulatory standards, while...

**About the Role**: We are hiring a CSV Engineer to support pharmaceutical manufacturing projects in Singapore. The role focuses on validating GxP computerised systems to ensure compliance with relevant regulatory and data integrity standards across the project lifecycle. **Key Responsibilities**: - Author and review validation documentation (URS, FS, RTM,...

**Responsibilities** - Work with Engineers to develop Computer Validation Strategy, plans, protocols, reports, risk assessment, requirement traceability matrix etc for any new or change induced validation system / activities. - Schedule, organize and coordinate at detailed site level, validation activities with cross functional groups - Assist in raising...