Carestream Dental Careers

IT Process Validation/ Computer Systems Validation Analyst

Atlanta, Georgia
Information Technology


Job Description

Job Duties:

  • Analyze the validation of computer and automation systems ensuring compliance to required regulatory requirements.
  • Partner with the Global IT Compliance organization to gain in-depth understanding of guidelines, requirements and general expectations related to Computer Systems Validation and Compliance
  • Deliver validation activities in compliance with US and EU regulations.
  • Participate in the design of systems, if needed, to ensure that they comply with GMP/GCP/GLP requirements.
  • Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
  • Initiate and implement change control activities in accordance with site procedures.
  • Compile and analyze validation data and make recommendations for improvements.
  • Participate on cross-functional project teams with the support of Validation activities.
  • Support Data Privacy Officer in conducting assessments and collecting evidence of compliance to support GDPR, HIPAA, PCI, and other privacy regulation regulatory documentation.

Day to Day Technical Responsibilities:

  • Author relevant validation documentation (e.g. Master Plans, Test Scripts, Templates, etc.), as defined by our SDLC methodology.
  • Execute all relevant validation protocols and test procedures, as defined by our SDLC methodology
  • Develop validation documentation as required (e.g. specifications, user requirements, plans, protocols, procedures, traceability matrix, error/defect reports, etc. ).
  • Execute qualification protocols as required.
  • Prepare reports of executed protocols for review by QA.
  • Track and resolve exceptions during qualification activities.
  • Proactively resolve conflicts between compliance requirements and project/business constraints.
  • Co-ordinate validation activities with IT, Business, QA activities.

Mandatory Requirements:

  • 4-6+ Years: Computer System Validation
  • 2-4+ Years: Medical Device/Pharmaceutical industry experience
  • Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11, Part 820, and GAMP standards are required.
  • Root cause analysis; experience investigating and troubleshooting automation and control systems
  • Ability to work in cross-functional team environments, as well as independently, and to work multiple and competing projects
  • Strong written and verbal communication skills
  • Knowledge of MS Office, SharePoint, MS Project, and Visio.

Desired Requirements:

  • Knowledge/familiarity with U.S. and Global regulatory registration of drug products is preferred.
  • International, cross culture, and cross functional experience desired
  • Project management skills
  • ISO-13485:2016 knowledge and experience
  • Certified Information Systems Auditor

 

TRAVEL

● Domestic and International (25%)

Job Duties:

  • Analyze the validation of computer and automation systems ensuring compliance to required regulatory requirements.
  • Partner with the Global IT Compliance organization to gain in-depth understanding of guidelines, requirements and general expectations related to Computer Systems Validation and Compliance
  • Deliver validation activities in compliance with US and EU regulations.
  • Participate in the design of systems, if needed, to ensure that they comply with GMP/GCP/GLP requirements.
  • Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
  • Initiate and implement change control activities in accordance with site procedures.
  • Compile and analyze validation data and make recommendations for improvements.
  • Participate on cross-functional project teams with the support of Validation activities.
  • Support Data Privacy Officer in conducting assessments and collecting evidence of compliance to support GDPR, HIPAA, PCI, and other privacy regulation regulatory documentation.

Day to Day Technical Responsibilities:

  • Author relevant validation documentation (e.g. Master Plans, Test Scripts, Templates, etc.), as defined by our SDLC methodology.
  • Execute all relevant validation protocols and test procedures, as defined by our SDLC methodology
  • Develop validation documentation as required (e.g. specifications, user requirements, plans, protocols, procedures, traceability matrix, error/defect reports, etc. ).
  • Execute qualification protocols as required.
  • Prepare reports of executed protocols for review by QA.
  • Track and resolve exceptions during qualification activities.
  • Proactively resolve conflicts between compliance requirements and project/business constraints.
  • Co-ordinate validation activities with IT, Business, QA activities.