Compliance and Quality Assurance Assistant

Description

As a Compliance & Quality Assurance Assistant, you will support the Compliance & Quality Assurance team in ensuring that all processes contributing to clinical trial performance are conducted in accordance with applicable regulations, industry standards, and internal quality requirements, including ICH Guidelines, GCP, and GCLP. In this role, you will contribute to the maintenance and continuous improvement of the Quality Management System (QMS), support audit activities, monitor compliance processes, and collaborate with internal stakeholders and external partners to uphold the highest quality standards.

We offer

• Stable employment based on an employment contract.

• Work Monday-Friday.

• The opportunity to participate in international researcher meetings (lasting several days).

Requirements

• Bachelor's or Master's degree in Natural Sciences, Quality Management, Life Sciences, or a related field.

Nice to have

• Previous experience in Quality Assurance, Compliance, Quality Management, or a regulated environment will be an advantage.

Strong interpersonal and communication skills.

• Proactive attitude and willingness to learn and develop within the quality and compliance area.

• Good working knowledge of MS Office (Word, Excel and PowerPoint).

• English proficiency at a minimum B2 level (written and spoken).

Strong organizational skills with the ability to manage multiple priorities and meet deadlines.

• High attention to detail while maintaining a broader business perspective.

• Ability to work effectively under pressure and in a dynamic environment.

Support vendor and subcontracted laboratory qualification processes, including maintaining qualification records and documentation.

• Monitor and maintain vendor and laboratory files to ensure completeness, accuracy, and compliance.

• Review employee training records and personnel documentation to ensure availability, completeness, and regulatory compliance.

• Collect, analyze, and report quality-related data, including Key Performance Indicators (KPIs) and quality metrics.

• Support the identification, documentation, investigation, and monitoring of risks, nonconformities, corrective actions, and mitigation plans.

• Assist in organizing, documenting, and delivering compliance, quality, and regulatory training activities.

• Support the evaluation and monitoring of external service providers, vendors, affiliate laboratories, and subcontracted laboratories.

• Promote quality, compliance, and ethical standards throughout the organization.

Good understanding of quality systems and regulatory requirements applicable to clinical research or healthcare environments is considered a plus.

• Knowledge of ICH-GCP, GCLP, ISO standards, or other quality and regulatory frameworks.

• Experience participating in audits or inspection-related activities.

• Experience working with Quality Management Systems (QMS).

Benefits including private health insurance for you and your loved ones, a subsidized fitness card, other services and products on the Medicover Benefits platform, and much more.

• The opportunity to work with a cooperative and friendly team.

• Work at a center that maintains high standards.

Support the Compliance & Quality Assurance team in monitoring key organizational processes and ensuring compliance with applicable regulations, standards, and internal procedures.

• Prepare audit documentation and participate in internal audits, as well as support external audits and inspections.

• Contribute to the maintenance and continuous improvement of the Quality Management System (QMS).

• Administer and maintain quality system documentation, including Standard Operating Procedures (SOPs), instructions, forms, and records.

• Assist with the preparation and execution of internal audit programs and related follow-up activities.