eQMS Specialist/ Quality Data Associate

Swixx Biopharma is staffed by a group of experts and medical professionals who are dedicated to bring modern medicines to the people! We are a service-oriented, high quality and ethically driven company.

With over 1,600 employees and sales which exceeded 900M Euros in 2023, Swixx has swiftly evolved into one of the largest and fastest-growing dedicated agents for biopharma in the Central, Eastern and Southeastern regions of Europe. 

The company opened in MENA in late 2023. In May 2024, Swixx expanded to Latin America with a strategic acquisition and combination with Laboratorios Biopas SA. Through Biopas’ comprehensive Latam continental coverage, Swixx is now able to provide a compelling offering covering Central and Eastern Europe, CIS/Eurasia, MENA and Latin America.

Swixx Biopharma has been recognized as one of Europe’s Fastest-Growing Companies for 2024 by the Financial Times (FT).

We are looking for a new team member for the position of eQMS Specialist/ Quality Data Associate​ (could be based in any country in Central and Eastern Europe).

YOUR ROLE

As a eQMS Specialist/ Quality Data Associate, you will:

The eQMS Specialist/ Quality Data Associate is responsible for performing routine monitoring of data in eQMS to ensure it complies with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, and more). This role includes oversight of quality processes, such as Corrective and Preventive Actions (CAPA), deviations, and other critical quality tasks within the eQMS. Additionally, the eQMS Specialist/ Quality Data Associate is responsible for monitoring and reporting on key performance indicators (KPIs) and conducting trend analyses to identify areas for improvement and support data-driven decision-making. It acts as a deputy for eQMS Business Owner for routine administration activities.

Key responsibilities:

Data Integrity Management:

• Conduct routine reviews of eQMS data, including audit trails, to ensure compliance with ALCOA+ principles.
• Ensure data accuracy, completeness, and traceability to maintain GxP compliance.

Quality Process Oversight:

• Oversee and manage Corrective and Preventive Actions (CAPA), deviations, and other quality-related processes within the eQMS.
• Ensure all quality processes are completed and documented in accordance with GxP requirements.

KPI Monitoring and Reporting:

• Track monthly KPIs related to Quality Assurance processes
• Conduct trend analyses on eQMS data to identify recurring issues, areas for improvement, and opportunities for quality enhancement.

Compliance and Documentation:

• Maintain and review records and reports to ensure all data is maintained accurately, completely, and in compliance with regulatory standards.
• Support audits and inspections by providing necessary documentation and reports related to eQMS data integrity.

Support and deputise Life Sciences Platform (eQMS & RIM) Business Owner in routine activities: user assess and support, master data management

YOUR PROFILE

Education

• University Degree in Pharmacy, Life sciences or related field

Previous Experience

• At least 3 years of work experience in the pharmaceutical industry on similar position
• Understanding of QA processes, regulatory PV processes is a plus

Language & Technical skills

• Fluent in English (verbal and written)
• Knowledge of MS Office, Adobe Acrobat, advanced MS Excel

Knowledge and expertise

• Experience in Quality assurance
• Experience with GxP IT systems (eQMS, RIM, etc)



Skills and abilities

• Communication, and teamwork skills.
• Effective collaborative abilities in a fast-paced setting.
• Ability to deliver results that meet high-quality requirements with tight deadlines.

WHAT YOU GET IN RETURN

• Opportunity to contribute & learn in customer-oriented & dynamic environment
• Be part of team driven by a cause
• Gain experience in multinational fast-growing company
• Collaborate with the best colleagues you could wish for

Sounds appealing? Please get in touch with us by submitting your application by 21. Feb 2025 to address: [email protected]

Only short-listed candidates will be contacted. All applications will be treated in strict confidentiality.