Covance, a leading global drug development services company, is looking for a System Specialist to join I&I Innovation Team based in Harrogate, North Yorkshire.
The System Validation resource performs a skilled technical role in the I&I Innovation Team.
This role will include special projects, instrument and systems validations. This requires a significant understanding of Computer System Validation (CSV), and worked performed in the life sciences compliance and regulatory framework.
The responsible person should have a working knowledge of laboratory instrumentation within a clinical laboratory and/or specific knowledge of CSV in a FDA regulated industry.
The job position will have specific delivery responsibilities and be able to work closely with both global and local management.
-Responsible for instrument validations within Global I&I in accordance with current Covance guidelines.
-Responsible for maintaining Covance Training file with appropriate training
documentation for the System Validation role.
-Coordinate closely with Global Business Technology (GBT) CSV team to ensure current guidelines are met in system validations.
-Coordinate closely with Quality Assurance (QA) team to ensure current guidelines and Standard Operating Procedures (SOP) are met for system validations.
-Coordinate the evaluation and recommendations of new instrumentation across Global I&I to ensure alignment of technologies where possible.
-May server as Point of Contact with relevant companies to obtain details on
goods/equipment as required.
-Responsible for introduction, implementation and continuing compliance of any instrumentation when required.
-Assist in the introduction of new techniques, methodologies and relevant procedures in collaboration with the Senior Technical Specialists where required.
-Ensure the Systems Inventory is up to date at all times
-Development, Review and Implementation of System Life Cycle Documentation, including but not limited to: Validation Plans, Risk Assessments, User Requirements, Traceability Matrix, Test Plans, Test Scripts, Defect/Error Logs, Deployment Plans, Change Management Plans, and Change Controls.
-Bachelor’s Degree and 2 years related experience, or at 3-5 years of experience with no degree.
-Working knowledge of analytical laboratory instrumentation
|-2 years related experience with a Bachelor's Degree|
-3 to 5 years related experience with no degree
-Previous Computer System Validation (CSV) experience, required.
-Previous analytical/laboratory instrumentation experience, preferred.
-Good Laboratory Practice regulatory experience, preferred.