GXP Validation Analyst
Posted on :
17-10-2022
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Job Description
- Consult project/client needs wrt validation and 21 CFR Part 11 GXP compliance testing procedures
- Performing Compliance evaluation of procedures and systems wrt equipment, facilities and computerized systems used in GLP, GMP and GCP environments.
- Coordinate with cross-functional project teams in for deliverables within the agreed timeline.
- Support development of best practices within the validation group, based on current industry practices and guidelines.
- Serve as quality representative and compliance resource, directing the application of company standards for internal validation activities, including quality review and approval of project deliverables
- Using in-depth professional knowledge, provide guidance to employees, external contractors, clinical investigators, and development partners on complex topics related to computer system regulatory requirements, data integrity, and quality systems
- Direct and train staff on regulatory requirements, quality management processes and procedures, and inspection readiness
- Conduct periodic assessment activities to ensure systems are operating in a compliant state and foster continuous improvement
- Collaborate with functional teams to ensure that the integrity of data and information is maintained throughout its lifecycle
- Quality Assurance/Audits
- Commensurate with expertise, plan and conduct internal and external audits of technology in use by customer and tool vendors providing computing services
- Guide functional teams through the deviation/CAPA process to ensure robust investigation, timely action, and meaningful improvements to process
- Using quality management system tools, analyze audit findings and deviation trends to drive continuous improvement
- Collaborate with external contractors conducting audits on behalf of customer. This may include co-auditing activities, providing information about company processes, known quality issues, audit scoping expectations, and/or guidance on use of the audit system
- Conduct or participate in Mock Regulatory Inspection activities and/or provide guidance to functional teams to facilitate inspection readiness
Employment Type
Full Time
Key Skills
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