IT Quality & Validation Specialist
Hikma Pharmaceuticals
Remoto
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, 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.
- Prepare and maintain validation documentation to ensure audit readiness.
- Address audit observations related to CSV activities under supervision from the CSV head.
- Participate in updating validation SOPs, templates, and guidelines as required.
- Assist in maintaining system inventory, validation status tracking, and lifecycle management oversight.
- 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).
- 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