Responsibilities: Lead computer system validation projects related to authoring and executing specifications... policies). Review and (remote) execute Computer System Validation protocols to ensure compliance and adherence with corporate...
be considered). 7+ years of experience in a Computer System Validation role within the pharmaceutical, biotech...Responsibilities: Possess hands-on experience with the Veeva Vault QualityDocs System. Develop Computer System...
Responsibilities: Designing and executing validation including support of computer system validation protocols... and product being validated). Ensuring product and process development activities have all necessary validation and supporting...
productivity. Additional requirement: "Strong expertise in Computer System Validation (CSV) processes and methodologies, ensuring... comprehensive Computer System Validation (CSV) plans, protocols (IQ, OQ, PQ), and reports to ensure SAP systems and associated...
in Computer System Validation (CSV) processes and methodologies, ensuring compliance with regulatory standards such as FDA 21 CFR... stakeholders, to ensure successful validation processes. Develop and execute comprehensive Computer System Validation (CSV) plans...
validation process and implementation of system upgrades, including guiding, testing, supporting the introduction and ongoing... evidence that the computer system consistently performs its intended functions accurately and reliably, proving the software...
Job Description The Quality Assurance (QA) Validation Lead is responsible for the Computer System Validation (CSV... to Computer System Validation principles and Quality Management Systems (21CFR Part 11, GAMP- 5, EU Annex 11 and other relevant...
technologies to maintain SHI’s competitive advantage in the evolving system integrator landscape. This position will report... and AI. Oversee the installation, configuration, validation, and troubleshooting of data center hardware and software, ensuring high...
Validation (CSV) and experience with System Development Life Cycle of automated computer systems within biopharmaceutical...Specific Job Responsibilities Responsible for performing validation of computer systems, process automation...
Computer System Validation Clinical Research lab instrument validation 21 CFR part 11 Client ALM... documentations for the instrument software validation. Own change controls and deviation management Prepare and execute IQ/OQ...