SAP Computer System Validation (CSV) Specialist

The SAP Computer System Validation (CSV) Specialist is a role within the RCM Life Sciences organization. The SAP Computer System Validation (CSV) Specialist will be responsible for supporting the validation of implementation and upgrade projects around SAP (and related technologies) for RCM's Life Sciences (Pharmaceutical, Biotech, Healthcare Medical Device) clients.

Responsibilities:

· Perform validation, where required, on the following SAP modules: Distribution, Finance, Inventory Management, Logistics, Procurement, Manufacturing Production, Project Management, Quality Management, Warehouse Management.

· Perform computer system validation projects related to updating, authoring and executing specifications and validation documentation for enterprise computer systems.

· Author or updated validation protocols ensuring that the technology solutions being implemented are compliant with all relevant regulations (i.e., 21 CFR Part 11, Annex 11, GxP, local and corporate policies).

· Execute Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures, cGMP and ISPE GAMP 5 guidelines and regulations.

· Understands how aspects of data integrity, security, access, and safety are addressed through the various protocols.

· Write risks assessments according to GMP and 21 CFR Part 11 compliance guidelines. Prepare validation summary reports for executed protocols.

· Investigate and resolve Deviations, CAPA investigations and other potential issues.

· Develop or update validation deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls.
 

Qualifications:

· Minimum of 5 years’ global experience in SAP Validation within the Life Sciences industry.
· Minimum of 2 years of experience with Solution Manager and Change Request Management (ChaRM).

· Perform validation, where required, on the following SAP modules: Distribution, Finance, Inventory Management, Logistics, Procurement, Manufacturing Production, Project Management, Quality Management, Warehouse Management.

· Perform computer system validation projects related to updating, authoring and executing specifications and validation documentation for enterprise computer systems.

· Author or updated validation protocols ensuring that the technology solutions being implemented are compliant with all relevant regulations (i.e., 21 CFR Part 11, Annex 11, GxP, local and corporate policies).

· Execute Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures, cGMP and ISPE GAMP 5 guidelines and regulations.
·Understands how aspects of data integrity, security, access, and safety are addressed through the various protocols.
· Write risks assessments according to GMP and 21 CFR Part 11 compliance guidelines. Prepare validation summary reports for executed protocols. · Investigate and resolve Deviations, CAPA investigations and other potential issues.
· Develops or updates validation deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls.
· Experience in IT deviations/investigations desired.

Last updated on Aug 24, 2023