Specialist - IT Quality

Specialist - IT Quality

Responsibilities

• Validation & Documentation:

  Lead all phases of computerized systems qualification and validation. You will review and approve validation packages, including

  Requirement Specifications, Design Specifications, Test Protocols

  , and

  Validation Summary Reports

  , ensuring compliance with regulatory requirements and internal standards.

• Deviation & CAPA Management:

  Serve as the primary QA contact for

  deviations

  and

  CAPA (Corrective and Preventive Actions)

  , ensuring proper investigation and timely resolution. You will also initiate and manage deviations as required and act as a quality reviewer for problem records.

• Change Control & Audits:

  Initiate, implement, and track the completion of

  Change Control

  requests related to computer systems. You will also review and approve periodic system reviews and audit trail reports to ensure system integrity.

• Supplier & GxP Compliance:

  Provide support for supplier evaluations and oversee GxP Computerized Systems programs and projects. You will also participate in and support regulatory inspections as required.

• Process Improvement:

  Apply strong analytical skills to evaluate complex problems, utilizing both qualitative and quantitative data to develop effective solutions. You will contribute to continuous improvement efforts and assist with training initiatives.

Qualifications

• A Master's degree with experience or a Bachelor's degree with extensive experience in

  Software and Systems Quality Assurance

  .
• A strong understanding of regulations such as

  21 CFR Part 11, EU Annex 11,

  and

  GAMP standards

  .
• Proven experience in the

  validation of computerized systems

  and a strong application of

  GxP regulations

  (GMP, GLP, GCP, GPvP, GDP).
• Experience managing quality assurance processes, including

  Change controls, Deviations, and CAPAs

  .
• Familiarity with tools and systems such as

  HP ALM, Jira, Confluence, and TrackWise

  .

Competencies

• Leadership:

  Strong leadership skills with experience leading projects, teams, or tasks.

• Problem-Solving:

  A demonstrated ability to handle and resolve complex quality issues using strong analytical and decision-making skills.

• Autonomy:

  The capacity to work independently with minimal supervision and drive tasks to completion.

• Collaboration:

  The ability to work closely with leadership and external experts to extend capabilities and enhance performance.