What are the responsibilities and job description for the Computer System Validation position at Katalyst CRO?
Responsibilities
Lead computer system validation projects related to authoring and executing specifications and validation documentation for enterprise computer systems.
Author 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).
Review and (remote) 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.
Assist, investigate and resolve Deviations, CAPA investigations and other potential issues.
Develops validation deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls.
Validates software for Laboratory and Manufacturing instruments.
Available to attend meetings as necessary.
Periodic Review activities.
Ability to manage three to four active projects.
Waters/Empower.
Various Laboratory Instrument Software.
Various Manufacturing Instruments Software.
Requirements
Other Enterprise Applications as Required.
BS/BA required in a related field.
5 years minimum required relevant experience.
Minimum of 7 years in the FDA regulated industry.
5 years Document Authoring experience, SOP revisioning experience and re-executing protocols.
Working knowledge of GMP, 21 CFR Part 11 and Annex 11.
Ability to work on multiple concurrent project initiatives.
Experience with Laboratory and Manufacturing Instrument Software Validation.
Experience in validating Enterprise systems (both on premise and cloud). Examples are SAP, Empower, Labware, Veeva.
Worked with different validation models from V-Model to CSA.
Ability to apply Agile and Waterfall methodology.
Excellent written and verbal communication skills.
Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.
Strong collaboration with colleagues at all levels.
Strong customer service and teamwork oriented.
Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships.
Highly flexible, adapting to changes in priorities, requirements and processes is required.
French language proficiency is a plus.
Lead computer system validation projects related to authoring and executing specifications and validation documentation for enterprise computer systems.
Author 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).
Review and (remote) 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.
Assist, investigate and resolve Deviations, CAPA investigations and other potential issues.
Develops validation deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls.
Validates software for Laboratory and Manufacturing instruments.
Available to attend meetings as necessary.
Periodic Review activities.
Ability to manage three to four active projects.
Waters/Empower.
Various Laboratory Instrument Software.
Various Manufacturing Instruments Software.
Requirements
Other Enterprise Applications as Required.
BS/BA required in a related field.
5 years minimum required relevant experience.
Minimum of 7 years in the FDA regulated industry.
5 years Document Authoring experience, SOP revisioning experience and re-executing protocols.
Working knowledge of GMP, 21 CFR Part 11 and Annex 11.
Ability to work on multiple concurrent project initiatives.
Experience with Laboratory and Manufacturing Instrument Software Validation.
Experience in validating Enterprise systems (both on premise and cloud). Examples are SAP, Empower, Labware, Veeva.
Worked with different validation models from V-Model to CSA.
Ability to apply Agile and Waterfall methodology.
Excellent written and verbal communication skills.
Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.
Strong collaboration with colleagues at all levels.
Strong customer service and teamwork oriented.
Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships.
Highly flexible, adapting to changes in priorities, requirements and processes is required.
French language proficiency is a plus.
