Subprojects included Distribution, Product Quality Complaints, Late Case Reporting, Engineering Docs, Issue Escalation, Batch Disposition.
Utilized KNEAT for document creation, test script execution, discrepancy management, and reviews. Employed ServiceNow for application change Control management.
Since 2002, I've excelled in validating computer systems crucial for Pharma, Medical Devices, and Life Sciences, ensuring that GMP manufacturing systems and GxP environments comply with quality standards. Skilled in supporting regulated IT infrastructure and fostering collaboration with team cooperation of business leaders, process owners, and experts. Adept at supporting Projects whilst working close to customers.
Creation, review and approval of validation and project lifecycle documents
Managing the CSV aspects ensuring robust and defendable validation
Proficiency in refining existing documents to enhance their overall clarity and effectiveness
Coaching and supervising of testers in good documentation practices according to industry best practices.
Previously engaged in remote transactions to ensure compliance and generate test evidence through proficient English language conversion.
Computer Systems Validation in the following industries:
Pharma, Medical Device, Biotech, Life Sciences
Subprojects included Distribution, Product Quality Complaints, Late Case Reporting, Engineering Docs, Issue Escalation, Batch Disposition.
Utilized KNEAT for document creation, test script execution, discrepancy management, and reviews. Employed ServiceNow for application change Control management.
Since 2002, I've excelled in validating computer systems crucial for Pharma, Medical Devices, and Life Sciences, ensuring that GMP manufacturing systems and GxP environments comply with quality standards. Skilled in supporting regulated IT infrastructure and fostering collaboration with team cooperation of business leaders, process owners, and experts. Adept at supporting Projects whilst working close to customers.
Creation, review and approval of validation and project lifecycle documents
Managing the CSV aspects ensuring robust and defendable validation
Proficiency in refining existing documents to enhance their overall clarity and effectiveness
Coaching and supervising of testers in good documentation practices according to industry best practices.
Previously engaged in remote transactions to ensure compliance and generate test evidence through proficient English language conversion.
Computer Systems Validation in the following industries:
Pharma, Medical Device, Biotech, Life Sciences