Job Description

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:

\xc2\xb7 Perform validation, where required, on the following SAP modules: Distribution, Finance, Inventory Management, Logistics, Procurement, Manufacturing Production, Project Management, Quality Management, Warehouse Management.

\xc2\xb7 Perform computer system validation projects related to updating, authoring and executing specifications and validation documentation for enterprise computer systems.

\xc2\xb7 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).

\xc2\xb7 Execute Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures, cGMP and ISPE GAMP 5 guidelines and regulations.

\xc2\xb7 Understands how aspects of data integrity, security, access, and safety are addressed through the various protocols.

\xc2\xb7 Write risks assessments according to GMP and 21 CFR Part 11 compliance guidelines. Prepare validation summary reports for executed protocols.

\xc2\xb7 Investigate and resolve Deviations, CAPA investigations and other potential issues.

\xc2\xb7 Develop or update validation deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls.

Qualifications:

\xc2\xb7 Minimum of 5 years\xe2\x80\x99 global experience in SAP Validation within the Life Sciences industry.
\xc2\xb7 Minimum of 2 years of experience with Solution Manager and Change Request Management (ChaRM).

\xc2\xb7 Perform validation, where required, on the following SAP modules: Distribution, Finance, Inventory Management, Logistics, Procurement, Manufacturing Production, Project Management, Quality Management, Warehouse Management.

\xc2\xb7 Perform computer system validation projects related to updating, authoring and executing specifications and validation documentation for enterprise computer systems.

\xc2\xb7 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).

\xc2\xb7 Execute Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures, cGMP and ISPE GAMP 5 guidelines and regulations.
\xc2\xb7Understands how aspects of data integrity, security, access, and safety are addressed through the various protocols.
\xc2\xb7 Write risks assessments according to GMP and 21 CFR Part 11 compliance guidelines. Prepare validation summary reports for executed protocols. \xc2\xb7 Investigate and resolve Deviations, CAPA investigations and other potential issues.
\xc2\xb7 Develops or updates validation deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls.
\xc2\xb7 Experience in IT deviations/investigations desired. About RCM:
RCM Life Sciences & IT is a leading provider of Engineering and IT Business Solutions Services to over 1,000 clients in the commercial and government sectors. RCM partners with clients to define, implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America & PR.

Equal Opportunity Statement
RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer
This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

#Monster

RCM Technologies