Head of Quality (RP/QP)

Responsibilities

• Oversee quality assurance for the secondary packaging facility and wholesale distribution activities at the site

• Ensure compliance with GMP requirements during pharmaceutical repackaging, including verification and provision of manufacturing documentation needed for product release or rejection

• Operate and continuously improve the quality management system

• Act as the primary point of contact for clients on quality-related matters (handling deviations, complaints, changes, CAPAs)

• Provide GxP training and supervision of staff

• Conduct risk assessments; manage the quality documentation system; oversee and approve SOP preparation

• Manage suppliers and handle quality agreements, including their approval

• Fulfill responsibilities as Qualified Person  and Responsible Person in accordance with applicable national regulations

• Serve as the key owner and operator of the site’s quality system in compliance with company policies as well as GMP/GDP guidelines

• Provide professional leadership and guidance to colleagues working in quality assurance

• Maintain effective communication with clients’ technical personnel and internal departments

Requirements

• University degree, preferably in pharmacy

• Experience required for QP/RP designation

• Proven track record in a similar QP/RP role, preferably in a warehouse or logistics environment

• Experience in regulatory inspections, audits, and preparation activities

• Fluency in Hungarian and English

• Advantage: prior leadership experience

• Agile, change-oriented personality with strong client-facing and negotiation skills
  
  Should you be interested in the opportunity please do not hesitate to submit your professional CV so we can contact you with the further details.