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Quality assurance specialist

Vila Real
Krka
Anunciada dia 28 março
Descrição

KRKA PHARMACEUTICALS, PT, LDA Looking for a creative and challenging opportunity? Then this opportunity is for you!We are looking forQuality Assurance Specialistwith 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 by15/04/2026 ! Join us!

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