Hiring.Camp

Quality eSystem Specialist

Alvotech

·

Today

Location
Reykjavik Headquarters, Iceland
Type
Full-time
Closing date
Today
Source
Workday

Description

Scope and responsibility:

  • Provide Quality Systems expertise and support for GxP electronic systems across the organization.
  • Support the administration, configuration, maintenance, and continuous improvement of quality-related electronic systems, including Veeva Quality, Veeva LIMS, MasterControl, and other regulated platforms.
  • Design, create, verify, and maintain system master data and data structures to ensure data integrity and regulatory compliance.
  • Support implementation of new functionality, system enhancements, and introduction of new electronic solutions.
  • Execute and support system validation activities, including testing, verification, and User Acceptance Testing (UAT).
  • Support investigation, troubleshooting, and resolution of system-related issues in collaboration with business and technical stakeholders.
  • Participate in cross-functional projects focused on digitalization, process improvements, and quality system enhancements.

Job requirements:

  • University degree in pharmacy, biotechnology, chemistry, biology, engineering, computer science, information systems, or a related field.
  • Experience working in the pharmaceutical, biotechnology, or other regulated industries is desired.
  • Experience supporting or administering GxP computerized systems.
  • Working knowledge of Quality Management Systems and GMP requirements.
  • Experience with systems such as Veeva, MasterControl, LIMS, SAP, or equivalent enterprise platforms is considered an advantage.
  • Understanding of computerized system validation principles and data integrity requirements is beneficial.
  • Excellent communication and team working skills.
  • Strong attention to detail and commitment to quality.
  • Proficient English skills are required.

Skills

SAPGMPCompliance