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IT Quality Validation Consultant
4 months ago
The Software Validation Quality Consultant will work closely with the clinical quality assurance systems lead to deliver on internal validation efforts and audits of client's vendors and computerized systems.
Essential Functions
• Participate in computer system and vendor audits for review of their Quality Management System, SDLC, including validation, and data integrity controls.
• Review CAPA and verification of CAPAs of system and vendor audits.
• QA approver for internal validation efforts.
• Act as liaison to the business for guidance and consultancy on software validation.
• Support health authority audits/inspections for inspection readiness.
Requirements:
• Bachelor's degree in associated functional disciplines including IT, Data Sciences and others.
• Software development familiarity with both Agile and Waterfall methodology.
• Minimum 3-5 years' experience in Pharmaceutical industry or similar.
• Minimum 1-3 years' experience Vendor / Computerized System Validation (CSV) Auditing experience
• Knowledge of regulations governing software validation and development.
• Knowledge of GCP/GMP is preferred.
• Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently.
• Ability to Travel.
• Location: Nutley or hybrid.
Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.Company DescriptionMaxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.\r
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Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.
