Key Responsibilities: As an Analytical Instrument Validation Specialist, you will play a crucial role in guaranteeing the systems of a global life sciences leader meet regulatory requirements and operate flawlessly. Your responsibilities will include:
- Reviewing, analyzing, and updating user and functional requirements through direct interaction with users.
- Conducting assessments of computer systems according to 21 CFR Part 11 standards.
- Executing regulatory and risk assessments in alignment with SOPs.
- Leading validation efforts in accordance with the GAMP V-Model methodology.
- Developing validation deliverables, including IQ, OQ, and PQ, ensuring all requirements are met.
- Reviewing and executing OQ, PQ, and OPQ test scripts with adherence to Good Documentation Practices.
- Performing dry runs and front-end testing for OQ and PQ phases.
- Collaborating with developers to resolve issues identified in test exception reports.
- Authoring and reviewing CAPAs and maintaining the Requirements Traceability Matrix (RTM).
- Assisting in the creation of Validation Summary Reports for OQ and PQ.
- Managing all validation documents utilizing Documentum.
- Participating in change control activities for computer systems following Change Control Policy.
Qualifications: To excel in this role, the ideal candidate should possess:
- A solid understanding of regulatory compliance and risk assessment, particularly within the context of analytical instrument validation.
- Proven experience in reviewing and updating user and functional requirements while engaging with end users.
- Familiarity with 21 CFR Part 11 standards and practical experience in their application to computer systems.
- Proficiency in executing validation activities following the GAMP V-Model.
- Strong documentation skills and the ability to execute test scripts while adhering to Good Documentation Practices.
- Experience in troubleshooting and collaborating with development teams to resolve issues.
- The capability to author and review CAPA and maintain the RTM.
- Strong organizational skills to manage validation documents and change control processes using Documentum or similar tools.
