Quality Assurance Manager & Responsible Person
Roche
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
**The Position**
**The Opportunity**
As **Quality Assurance Expert/ Responsible Person / Qualified Person** , you will be in charge of transport and artwork compliance check of imported products, placing products on saleable stock, as well as quality control of storage, distribution and management of quality assurance status in the inventory management system.
+ Being responsible for quality oversight of Roche Hungary Ltd. warehouse according to local and EU regulations, and Roche requirements - this includes on site activities during product sampling after inbound delivery arrives, in cooperation with EU QPs during qualification and release of medicinal products, as well as to oversee and address any quality assurance issues or queries that may arise during product handling
+ Serving as the deputy to the Senior Qualified/Responsible Person/QA Lead, undertaking administrative and operational responsibilities
+ Provide immediate support and guidance to warehouse staff to ensure quality standards and compliance throughout all stages of product handling.
+ Develop and maintain comprehensive quality documentation (manuals, SOPs), ensuring they comply with GMP/GDP/Roche requirements, are up-to-date, and accessible.
+ Evaluate new suppliers and service providers based on quality criteria and regulatory requirements, and collaborate during external/internal audits and health authority inspections.
+ Perform thorough risk assessments to identify potential quality risks, develop and implement risk mitigation strategies, and investigate quality deviations to implement corrective and preventive actions (CAPA).
+ Develop and deliver training programs on quality assurance topics, ensure relevant employees are adequately trained on quality standards and procedures, and evaluate the effectiveness of training programs to enhance knowledge and compliance.
**Who you are**
+ Compliance with the requirements of 39/2004. (IV. 26.) ESzCsM Decree regarding the qualification of the qualified person and the responsible person, e.g.: Pharmacist degree (or equal based on Paragraph 3. § (1) ), at least 2-3 year of experience in the field of quality assurance of medicinal products at one or more economic organisations with a pharmaceutical wholesaler licence
+ Experience with tools like SAP, Veeva, Orca, and demonstrating strong stakeholder management, independent problem-solving, critical thinking abilities, and agile skills with flexibility to adapt to changes.
+ Ability to drive and facilitate daily work, projects, processes, and initiatives efficiently, while being detail-oriented, well-organized, and managing time effectively to multitask, prioritize, and handle problems and escalations.
+ Strong service and customer orientation with assertive communication skills, business acumen, impactful customer and stakeholder communication, excellent consulting, presentation, and negotiation skills, and experience working effectively with cross-functional groups.
+ Demonstrating an enterprise, entrepreneurial and enabler mindset, growth mindset with the ability to learn and unlearn quickly, a sense of ethics and morality displaying integrity, and finding passion in achieving successful outcomes by inspiring others and actively demonstrating VACC (Visionary, Architect, Catalyst, and Coach) principles.
+ Fluent in local language and proficient in English to collaborate internally across the broader Roche enterprise is expected.
**Who we are**
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
**Roche is an Equal Opportunity Employer.**
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