What are the responsibilities and job description for the Computer System Validation position at Katalyst Healthcares & Life Sciences?
Job Description
Job Description
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.
- Other Enterprise Applications as Required.
Requirements :
