CSV Consultant

Location: Manchester, NH
Department: Azzur Austin, LLC

Job Description

We at Azzur Group are looking for an experienced Computer System Validation Consultant to join our Azzur Consulting: Austin team.

Responsibilities: 
  • Ensures regulatory requirements and policies pertaining to analytical instruments and computer software applications and Data Integrity are met.
  • Author, review, execute, and approve QC analytical instrument and software validation deliverables such as VP, RA, IQ, OQ, PQ and Reports.
  • Review and approve vendor validation documents. Provide validation decisions – identify validation activities/documents depending on complexity and criticality and SISPQ impact of the system/equipment.
  • Perform technical, root-cause analysis for complex system issues or errors and completes recommended solutions.. Ensures data integrity IT/OT security by configuring computer OS and application security policies, file/folder permissions, data back-up scheduler, instrument parameters and method templates.
  • Provide data to CSV management for all aspects of analytical instruments and software used in QC laboratories. Interface with Validation, Quality Assurance, Engineering, IT, System Owners, and key stakeholders to facilitate timely protocol execution and remediate issues during protocol execution.
  • Authors GMP procedures, as required.
  • Perform/Review system risk assessments, as individual reviewer or collaborative reviewer, ensuring alignment to risk assessment processes.

Requirements: 
  • Engineering Degree required.
  • 2-6 years experience with Computer System Validation in a regulated environment
  • Familiar with regulatory guidance – MHRE, ISPE, GLP, GMP, GAMP
  • Familiar with validation of QC systems: Empower, MODA, LabX, LIMS
  • Working knowledge of FDA and cGMP regulations and documentation practices.
  • Excellent written and verbal communication and technical writing skills.
  • Proficient in Microsoft Office Suite and able to learn new computer applications.
  • Must be results oriented with hands-on experience with validation execution, familiar with industry concepts, practices and procedures in a cGMP environment





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