Computer System Validation Specialist at HAL Allergy

As Computer Validation Specialist you plan, execute, and lead computer/software validation project assignments including: implementation of new systems, remediation of legacy items, and re-validation of existing computerized systems. Implementation of guidance & regulations, e.g. data integrity.

Tasks and responsibilities

  • You manage the full lifecycle of validation projects including but not limited to delivery on time and to agreed specification to ensure delivery.
  • You write and assist in writing, all validation deliverables within the Computer System Lifecycle, e.g. Validation Plans, Summary Reports, risk assessments, Configuration Specifications, traceability matrix, SOP’s, Test Protocols & Reports and Change Controls.
  • In order to maintain the validated state of computerized systems you write effective system and process documentation.
  • Performing impact assessments for systems to include classification against GAMP principles.
  • System audit trail reviews.
  • Ensure GxP automated production and laboratory systems are maintained in a validated state.
  • Maintain inventory of critical GxP software.
  • Expertise in requirements for 21 CFR Part 11, Data Integrity, Annex 11, GxP and the underlying principles of each.
  • SME for CSV topics during regulatory inspections & client audits.
  • Lead risk assessments for system upgrades & critical patches.
  • Initiate continuous improvement of validation strategies and procedures by preparing changes or draft new validation procedures.
  • Plan, schedule, execute, and lead pharmaceutical validation project assignments including: implementation of new systems, remediation of legacy, and re-validation of existing computerized systems.
  • Advise and train employees on validation approaches and practises.
  • Serve as first point of contact for companies that are engaged in special activities/services related to validation strategies.
  • Prioritize, manage, and execute multiple projects utilizing Project Management methodology.
  • Knowledge of quality records, e.g. deviations, CAPA’s, change controls, complaints.

Personal and professional skills

  • You have a bachelor degree with an IT or software specialization and at least 5 years of experience.
  • In-depth knowledge of FDA and European compliance regulations and GAMP guidelines applicable to computer system validation.
  • In-depth knowledge of validation deliverables associated with each step of the computer system life cycle.
  • You are able to evaluate automation systems from a compliance perspective and ensure adherence to applicable standards (i.e. 21CFR Part 11, EU Annex 11).
  • You are familiar with computer system infrastructure, including: networks, servers, related hardware and supporting software, and peripheral hardware.

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