Quality Assurance Specialist

KRKA PHARMACEUTICALS, PT, LDA

Looking for a creative and challenging opportunity?

Then this opportunity is for you!

We are looking for Quality Assurance Specialist with ambition, passion for challenges, and a genuine desire to keep learning. If you are detail oriented, driven by continuous improvement, and motivated to enhance processes, this opportunity could be the perfect fit.

Your key responsibilities:

• Ensure strict compliance with GDP standards, regulatory requirements, and internal procedures.
• Ensure full traceability (batches, certificates, records), proper technical documentation, and effective change control.
• Manage change control processes, ensuring all GxP-relevant changes are properly assessed, approved, and implemented in line with regulatory requirements.
• Oversee product complaints, ensuring proper investigation by suppliers and appropriate handling within KRKA's QMS.
• Review and follow up on Product Quality Reviews (PQRs), ensuring trends are identified and CAPAs are effectively implemented.
• Monitor supplier performance using KPIs and quality metrics, driving continuous improvement and supplier development initiatives.
• Support the KRKA global audit program by planning, preparing, and conducting audits of external suppliers (on-site and remote).
• Perform transport risk assessments to ensure product integrity across the distribution chain.
• Collaborate cross-functionally with internal stakeholders to support product lifecycle management and CMO activities.
• Participate in quality-related and continuous improvement projects aligned with the Quality Strategy.
• Maintain and update Quality procedures, work instructions, and related documentation within your area of responsibility.
• Draft and maintain Quality Agreements with external partners (e.g., CMOs, service providers).
• Support the preparation, execution, and follow-up of internal and external audits and regulatory inspections.

We are looking for:

• Degree in Pharmacy, Biology, Chemistry, Engineering, or a related field.
• 2-5 years of experience in Quality Assurance, preferably within the pharmaceutical industry.
• Solid knowledge of GDP (Good Distribution Practices).
• Experience in audits (internal and external), deviation/non-conformity management, and CAPA processes.
• Strong attention to detail, with a high level of responsibility and reliability.
• Ability to work independently with accuracy and organization.
• Fluency in English (written and spoken).
• Strong teamwork skills, with the ability to collaborate in cross-functional and international environments.
• Analytical mindset with strong problem-solving skills.
• Proactive attitude, curiosity, and willingness to learn.
• Commitment to quality and continuous improvement.

Our Offer:

• Employment in a stable and successful pharmaceutical company in the Portuguese market;
• An international company that is constantly expanding its product portfolio to ensure success and competitiveness;
• Multicultural environment;
• Team collaboration;
• Well organized working environment;
• Opportunities for professional development;
• Opportunity to develop your skills and competencies.

If you enjoy the pharmaceutical industry, a dynamic and fun environment, send your CV by 15/04/2026!

Join us!