The Role
Provides expertise and support for GxP quality systems, including administration, configuration, master data management, validation, testing, UAT, troubleshooting, and continuous improvement. Supports Veeva, MasterControl, LIMS, and other regulated platforms while ensuring data integrity, GMP compliance, and effective implementation of system enhancements and digitalization projects.
Summary Generated by Built In
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 Required
- University degree in pharmacy, biotechnology, chemistry, biology, engineering, computer science, information systems, or a related field
- Experience supporting or administering GxP computerized systems
- Working knowledge of Quality Management Systems and GMP requirements
- Excellent communication and teamwork skills
- Strong attention to detail and commitment to quality
- Proficient English skills
- Experience working in the pharmaceutical, biotechnology, or another regulated industry
- Experience with Veeva, MasterControl, LIMS, SAP, or equivalent enterprise platforms
- Understanding of computerized system validation principles and data integrity requirements
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The Company
What We Do
Alvotech is a global biotechnology company focused exclusively on developing and manufacturing biosimilar medicines. Its mission is to improve patients’ lives by expanding access to affordable biologic treatments worldwide. The company operates as a fully integrated specialty biopharmaceutical business, pursuing high-quality biosimilars and building treatment options that can make important biologic therapies more accessible to patients through its research, development, and production capabilities.
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