IT CSV Specialist - Quality & Validation

Hikma Pharmaceuticals; Sintra; Híbrido; EUR 52 000 - 72 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Direct contract with Hikma

Competitive salary

Life insurance

Health Insurance extended to student 子

Annual Performance Bonus

Real Growth Opportunities

Resumo da oferta

Hikma Pharmaceuticals in Portugal is recruiting a Specialist, Computer System Validation, to join Corporate CSV/GRC/IT in a hybrid work model. The role focuses on CSV execution for GxP systems, audit support, and lifecycle management, requiring a Bachelor’s degree and 3–5 years of IT validation experience.

You will interact with IT and QA teams, participate in regulatory inspections, and help maintain validation documentation and SOPs.

Qualificações

• Good communication and problem-solving skills.
• Strong documentation skills to maintain accurate records of changes, policies and procedures.
• Ability to manage multiple tasks and priorities in a dynamic work environment.
• Able to work independently as well as part of a team.

Responsabilidades

• Prepare, execute, and maintain CSV deliverables for GxP systems, including Validation Plans, URS, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols, and Validation Summary Reports.
• Support periodic system reviews, revalidation activities, and change control impact assessments.
• Act as Validation representative for IT system implementation and upgrade projects.
• Support internal and external audits and regulatory inspections.

Conhecimentos

Communication skills

Problem-solving

Documentation skills

Independent work

Formação académica

Bachelor’s degree in Computer Science, IT, Engineering, or related field

Descrição da oferta de emprego

Hikma Pharmaceuticals in Portugal is recruiting a Specialist, Computer System Validation, to join Corporate CSV/GRC/IT in a hybrid work model. The role focuses on CSV execution for GxP systems, audit support, and lifecycle management, requiring a Bachelor’s degree and 3–5 years of IT validation experience.

You will interact with IT and QA teams, participate in regulatory inspections, and help maintain validation documentation and SOPs.