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Quality Director

Régió: Komárom-Esztergom

HAYS Hungary Kft.
Hozzáadva: 2017.11.12.
Jelentkezési határidő: 2017.11.24.
Hirdetés azonosító: 1198397

 

 
 
Quality Director
Quality Director position is open at our multinational pharmaceutical client. The main aim of the position is to lead the packaging, regional testing & release quality units and also to establish and operate the site Quality Management System, oversee the review and approval of products for commercial distribution and develop quality standards for the assurance of Good Manufacturing Practice consistent with regulatory requirements and company site objectives.

The main responsibilities of the Quality Director position are:
  • Ensuring the independence of the Quality Department in decisions on Quality related matters.
  • Organising and resourcing the Quality Department to meet current and future business demands.
  • Hosting of all Regulatory Authority inspections and Corporate Audits and ensuring the site is inspection-ready.
  • Primary contact for all matters relating to defect reporting to OGYEI.
  • Identification of key quality trends to the management team to ensure proactive maintenance of high quality standards and status of compliance.
  • Ensuring that the site Pharmaceutical Quality Systems and third party contractors meet current Quality and Regulatory Standards.
  • Ensuring that all drug products are manufactured and tested to the requirements of GMP and provide leadership and support to the Quality Units to ensure that any deviations from procedures/instructions and/or abnormal events are investigated and documented and suitable corrective/preventative actions are taken.
  • Ensuring support facilities for storage and testing of stability batches.
  • Overall responsibility for the handling and storage of Controlled Drugs in accordance with relevant procedures, ensuring product security at all times.
  • Sourcing and implementing Quality Management System tools to support improvements in Business Processes.
  • Reviewing departmental business operations/strategies and evaluate possible integration of new tools and technology to increase departmental efficiencies and effectiveness.
  • Providing leadership to the Quality Department with regard to annual individual objective setting and measurement, creation and management of development plans, career planning guidance and coaching.


The main requirements of the Quality Director position are:

  • Educated to degree level and 10 years plus in front line experience in pharmaceutical drug product QA/QP/QC/Manufacturing position in a wide portfolio of dosage forms (preferably to include oral solid dose).
  • Preferably hold QP qualification recognised by OGYEI.
  • Experience of front line regulatory interaction (e.g. OGYEI, MHRA).
  • Experience in facility, equipment and cleaning commissioning/ qualification/ validation.
  • Excellent knowledge of English and Hungarian.
  • Practical first-hand experience in either: drug product manufacture, analytics or quality management.
  • Have a clear understanding of the practical application of the rules of pharmaceutical GMP.
  • Have a clear track record of leadership in quality and previous senior management responsibility.
  • Capable of forming strong professional relationships across all functional lines and gain the respect of those in partner lines.
  • Experience delivering complex projects on time in budget.
  • Must be a clear communicator and able to make clear reasoned decisions under pressure.
  • Continuous improvement and operational excellence focus.

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.
 

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