Quality Assurance Specialist állás Országos

Jelentkezem

In this role, you will be the guardian of quality, ensuring that the company’s operations meet the highest regulatory standards while supporting business continuity.

Quality Assurance Specialist

Feladatok

Drive the Quality Management System (QMS)

Ownership: You will lead the implementation and continuous improvement of the local QMS, ensuring all SOPs and quality records are up-to-date and effective.
Compliance: Act as the local expert for GDP and GMP requirements, safeguarding product integrity across the entire commercial affiliate.

Manage Quality Operations & Issues

Problem Solving: Oversee the CAPA, Deviation, and Change Control processes to ensure any quality issues are resolved and prevented in the future.
Market Safety: Manage product complaints, handle secondary release processes with authorities, and support recall or counterfeit investigations if necessary.

Audit & Training Leadership

Audit Management: Plan and conduct internal audits, and act as the primary point of contact during external inspections and regulatory audits.
Knowledge Hub: Empower the team by delivering engaging QA training and ensuring everyone stays compliant with the latest procedures.

Strategic Partnerships & Coordination

Partner Quality: Manage Quality Agreements with vendors and local partners, and handle the qualification of product recipients.
Cross-functional Collaboration: Work closely with international teams (e.g., Polish QA) on reworking processes and coordinate with the business side during product shortages.
NMVO Contact: Serve as the main point of contact for NMVO-related alerts and agreements.

Elvárások

Education: University Degree in Medicine or Pharmacy
Experience: At least 3 years experience in Quality Assurance within the pharmaceutical or healthcare sector.
Expertise: Deep understanding of GDP and GMP regulations and hands-on experience with audits and CAPA management.
Skills: Strong communication skills in English and Hungarian, with an eye for detail and the ability to work cross-functionally.
Proactivity: A self-starter mindset with the ability to manage multiple priorities in a dynamic environment.

Előnyök

Amit ajánlunk

Competitive salary and comprehensive benefits package
A stable and reliable position within a well-established pharmaceutical company
Opportunity to work in a supportive and professional team
Home office option
Modern working environment and strong quality-driven company culture

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