IT Quality & Validation Specialist

Hikma Pharmaceuticals; Sintra; Presencial; 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

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Title: IT Quality & Validation Specialist

Description:

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 an 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, andmaintainCSV deliverables forGxPsystems, 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.

Audit & Inspection Support:

• Prepare and maintain validation documentation to ensure audit readiness.
• 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.

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
• Basic understanding of GxP regulations and computerized system compliance requirements. (21 CFR Part 11 and Annex 11 )
• Experience in preparing validation documents and supporting system testing activities.
• Good communication and problem-solving skills.
• Ability to manage multiple tasks and priorities in a dynamic work environment.
• Able to work independently as well as part of a team.
• Strong documentation skills to maintain accurate records of changes, policies and procedures.
• Languages: Fluent in Portuguese and English (written and spoken).

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, within everyone's reach, every day