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Open nowPosted 76 days ago

Responsible Person / Qualified Person (RP/QP)

Oximio14 open roles

Where
Törökbálint, Pest, Hungary
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Your applicationOpen nowResponsible Person / Qualified Person (RP/QP)Oximio · Törökbálint, Pest, Hungary

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Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.7%14 days
  5. 35.6%30 days
  6. 58.0%60 days
This job: posted 76 days ago

The posting

Oximio is a global logistics service provider supporting clinical research by delivering reliable and high-quality clinical trial logistics solutions worldwide. Our licensed facility in Törökbálint, Hungary provides GDP and GMP activities, including customs clearance, import-related services, packaging, labeling, storage and distribution of medicinal products. We are now looking for an experienced Responsible Person / Qualified Person (RP/QP) to join our growing Hungarian team and oversee the quality and regulatory compliance of our pharmaceutical wholesale and clinical trial logistics activities. Key Responsibilities Act as the Responsible Person (RP) and Qualified Person (QP) for applicable pharmaceutical and clinical trial activities in accordance with EU GDP/GMP requirements and local legislation. Provide quality oversight of the purchasing, receipt, storage, distribution and release of medicinal products. Ensure compliance with applicable GDP, GMP and GxP requirements throughout the pharmaceutical supply chain. Assess, investigate and document incoming product quality issues, including damaged, expired or non-conforming products. Establish, maintain and continuously improve the Quality Management System in line with GDP, GMP, GCP and ISO requirements. Develop, review and approve SOPs, work instructions, quality documentation and quality agreements. Plan, conduct and oversee internal self-inspections, supplier and manufacturer audits, and support customer and regulatory authority inspections. Lead and oversee CAPA, deviation, change control and risk assessment processes. Monitor storage conditions, temperature compliance and product handling activities. Ensure appropriate implementation of FEFO, product segregation, destruction, recall and product withdrawal procedures. Review and approve validation and qualification activities related to GDP/GMP operations. Ensure appropriate documentation, traceability and record keeping for quality-related activities. Deliver GDP/GMP/GxP training and provide quality guidance to employees and relevant stakeholders. Liaise with competent authorities, customers, Marketing Authorisation Holders and business partners on quality and regulatory matters. Monitor changes in applicable legislation and regulatory requirements and ensure their implementation. Support continuous improvement initiatives and promote a strong quality culture across the organisation. Requirements University degree in Pharmacy or an equivalent qualification required for RP/QP appointment under applicable local legislation. Proven experience working as a Responsible Person (RP) within a GDP-regulated pharmaceutical environment. Proven experience as a Qualified Person (QP) under EU GMP regulations. Strong knowledge of EU GDP, GMP and GxP requirements. Experience in Quality Management Systems, audits, inspections and regulatory compliance. Experience in pharmaceutical wholesale activities is highly desirable. Experience in clinical trial supply or clinical trial logistics is an advantage. Strong analytical, organisational and problem-solving skills with excellent attention to detail. Excellent communication and stakeholder management skills. Ability to work independently while collaborating effectively with international and cross-functional teams. Professional proficiency in English, both written and spoken. 5+ years of relevant pharmaceutical/quality experience. Benefits Join a growing international company supporting clinical research worldwide. A key quality and regulatory role within a licensed pharmaceutical logistics operation. Opportunity to work across both commercial pharmaceutical wholesale and clinical trial logistics activities. Collaboration with international Quality, Operations, Regulatory and Commercial teams. Professional development and exposure to a broad range of GDP/GMP activities. A supportive and collaborative working environment.

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