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Head of Quality Assurance

Régió: Budapest

HAYS Hungary Kft.
Hozzáadva: 2015.11.19.
Jelentkezési határidő: 2015.12.02.
Hirdetés azonosító: 971541


Head of Quality Assurance
Our client is a global ethical pharmaceutical company with extensive product portfolio and robust R&D pipeline in several therapeutic areas.

We are seeking an achieved quality assurance leader with proven record in the pharmaceutical industry and QP qualification to head up the QA organization in their Hungarian affiliate.


• Lead the local QA organization to ensure implementation, maintenance and upgrading of the local Quality System and SOPs in order to drive compliance of all cGXP and Pharmacovigilance related processes.

• Ensure quality governance and quality planning in the Hungarian affiliate through the establishment and implementation of the annual Quality Plan, appropriate Key Quality Indicators and leading the Quality Review Board.

• Ensure Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) oversight and quality & compliance of Clinical Development and Medical Affairs projects, products and programs (Phase I through Phase IV).

• Ensure efficient information flow and effective communication of all relevant quality matters within the Hungarian affiliate.

• Maintain current knowledge of local and international regulatory and legislative requirements and communicate local regulatory requirements to Global Quality Assurance.
• Ensure an adequate process is in place to report and monitor the predefined KQI’s, in alignment with Global QA and local affiliate. Assure that gaps are addressed appropriately and escalate critical trends to Management Team and Global QA.

• Provide quality oversight and direction to local third parties and ensure that they are qualified to perform their activities.

• Ensure that all drug products and Investigational Medicinal products (IMP) are released in accordance with the registered specifications.

• Ensure readiness of local affiliate for all GxP regulatory inspections. Ensure management of external inspections, complaints, deviations, recalls, counterfeits and product tampering.

• Ensure that local audits and self-inspections are performed within the organization and at 3rd parties, as appropriate. Ensure that any deficiencies identified through audits or other means are addressed.

• Ensure that within the local affiliate a GxP training program is established and training timely performed, documented and its effectiveness checked.

• Ensure that competent Quality personnel is available and trained ensuring the required qualification. Ensure people development of QA staff.


• PharmD or other university degree in Life Science related discipline.
• Proven track record in quality assurance (GMP and/or GDP) in the pharmaceutical industry
• Legislative requirements for QP qualification must be met
• Fluent English and Hungarian
• People management experience is a definite plus
Munkavégzés helye: Budapest

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