Specialist, Computer System Validation

Hikma Pharmaceuticals; Portugal; Presencial; EUR 40 000 - 60 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Life insurance

Health Insurance extended to student children

Annual Performance Bonus

Real Growth Opportunities

Resumo da oferta

Hikma Pharmaceuticals in Portugal seeks a Specialist in Computer System Validation. You will prepare and execute validation documentation for GxP systems, ensuring compliance with regulations and standards.

The ideal candidate has a bachelor's degree in Computer Science, 3-5 years of experience in regulated IT environments, and strong communication skills. The role offers a hybrid work model and various benefits, including life and health insurance.

Qualificações

• 3-5 years experience in IT Computer System Validation or regulated environments.
• Solid understanding of GxP, GAMP 5, and 21 CFR Part 11.
• Experience in writing technical documentation.

Responsabilidades

• Prepare and maintain CSV deliverables for GxP systems.
• Perform validation testing activities and document results.
• Support periodic system reviews and change control assessments.

Conhecimentos

Communication skills

Problem-solving skills

Organizational skills

Collaboration

Technical documentation writing

Formação académica

Bachelor’s degree in Computer Science or related field

Ferramentas

ERP

LIMS

QMS

Descrição da oferta de emprego

Specialist, Computer System Validation

Founded by Samih Darwazah over 40 years ago in Jordan, Hikma's purpose is to provide affordable, quality medicines to people in need. Based on very solid foundations, we continue to innovate daily and find practical solutions to transform the lives of the millions of people we serve.

At the end of the 1980s, we extended our footprint beyond the Middle East and acquired land in Portugal to build a sterile factory for injectable pharmaceutical products. This was an important turning point for the company, and our first step into a new region. Today, in Portugal, we have more than 1000 employees and 3 factories for the production of injectable medicines.

Hikma intends to recruit a Specialist, Computer System Validation (m/f) to integrate Corporate CSV/GRC/IT Department, on a hybrid work model.

Main Responsibilities

Computer System Validation Execution

• 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.
• Perform validation testing activities, ensuring results are properly documented and deviations are recorded, investigated, and resolved.
• Support periodic system reviews, revalidation activities, and change control impact assessments.
• Ensure compliance with GxP requirements, GAMP 5 guidance, ALCOA+ data integrity principles, and applicable regulations (21 CFR Part 11 / Annex 11).
• Act as CSV representative for IT system implementation and upgrade projects.
• Support internal and external audits and regulatory inspections.
• Collaborate closely with Quality Assurance, IT teams, business stakeholders, and system vendors.
• Contribute to continuous improvement of CSV processes, templates, SOPs, and validation lifecycle management practices.

Audit & Inspection Support

• Prepare and maintain validation documentation to ensure audit readiness.
• Support the preparation of audit response packages and participate during regulatory inspections.
• Address audit observations related to CSV activities under supervision from the CSV head.

Compliance Monitoring & Continuous Improvement

• Participate in updating validation SOPs, templates, and guidelines as required.
• Assist in maintaining system inventory, validation status tracking, and lifecycle management oversight.
• Identify areas for improvement in validation processes and propose practical solutions.

Profile

• Bachelor’s degree in Computer Science, Information Technology, Engineering, or related field.
• 3-5 years experience in IT Computer System Validation or regulated IT/Quality environments.
• Solid understanding of GxP, GAMP 5, Data Integrity (ALCOA+), and 21 CFR Part 11/Annex 11.
• Experience in writing technical documentation and executing testing activities.
• Strong communication and problem-solving skills.
• Ability to collaborate effectively with cross-functional and cross‑regional teams.
• Strong documentation and communication skills.
• Strong organizational skills and the ability to work effectively in a high‑paced, fast‑changing environment, results‑oriented.
• Ability to manage and prioritize tasks effectively, especially in the context of projects.
• Ability to work independently with minimal supervision, while being able to work with a diverse team with varying skill level.
• Strong documentation skills to maintain accurate records of changes, policies and procedures.
• Languages: Portuguese and English (written and spoken).
• Experience with ERP, LIMS, QMS, or other GxP computerized systems.
• Familiarity with risk-based and critical thinking approaches aligned with CSA principles.
• Previous audit or inspection exposure.
• Familiarity with AI-related standards applicable to GxP environments.

We Offer

• Direct contract with Hikma.
• Competitive salary aligned with the role.
• Life insurance.
• Health Insurance extended to student children (up to age 24).
• Annual Performance Bonus.
• Real Growth Opportunities.

If you think this is a good opportunity for your professional career, join us and contribute to better health every day.