Quality and Regulatory Director

Quality and Regulatory Director

Grifols

Prague, Czech Republic

What your responsibilities will be

Responsible for maintaining a Quality System based in GMP/GDP and the certification in ISO 9001:

  • Elaborate and approve SOP;
  • Training of personnel in GMP/GDP;
  • Management of customer complaints and deviations;
  • Elaborate and monitor a self-inspection plan;
  • Warehouse activities supervision.

Registration of medicinal products in the countries of Grifols sro. Area:

  • Ensure translation of SPC, package inserts and packaging materials into local languages in accordance with the requirements of national regulatory authorities in the countries of Grifols sro. Area;
  • Applications for registration, requests for changes in registration and applications for renewal on the national regulatory authorities and dealing with them during the proceedings;
  • Monitoring of current legislation regarding the registration of drugs and their distribution in the countries of Grifols sro. Area;
  • Batch release with the national regulatory Authority (haemoderivates), register of imported medicinal product for reporting.

Approval/notification of medical devices and in vitro diagnostics to the relevant authorities in the countries of Grifols sro. Area:

  • Applications for registration, requests for changes in registration and applications for renewal on the national regulatory authorities and dealing with them during the proceedings;
  • Monitoring of current legislation concerning on the registration of medical devices and in vitro diagnostics, their distribution in the countries of Grifols sro. Area.

Pharmacovigilance in the countries of Grifols sro. Area:

  • Reporting of adverse drug reaction;
  • Literature monitoring;
  • National contact person for communication with the regulatory Authority in Czech Republic and Slovak Republic;
  • Auditing of plasma suppliers, plasma transport and plasma storage in accordance with GMP;
  • Internal auditing of Grifols s.r.o. warehouse and plasma transport;
  • External auditing of warehouse and plasma transport in the contracting company in Slovak Republic;
  • External auditing of plasma suppliers for Instituto Grifols, Spain;
  • Support of Plasma Master File update;
  • Management of Look Back reporting of the Czech and Slovak plasma suppliers.

Auditing of distributors in accordance with GDP in the countries of Grifols s.r.o. area:

  • Performing of external audits;
  • Handling of complaints with producer, quality defect, suspicion to falsified product;
  • Cooperation within medicinal product/medical devices recall.

Who you are

  • Bachelor Degree in Life Science (Pharmacy, Medicine, Veterinary Medicine, Chemistry or Biology). Master in Pharmaceutical Industry would be a plus;
  • Minimum 5 of years of experience in a similar position taking care of Quality and Regulatory Affairs matters in the territories. Experience in Quality System based on ISO 9001 is preferred. Acquired practical experience over at least two years with one or more manufacturers of medicinal products in the sphere of quality assurance;
  • High Level of English and Czech;
  • High profile role that demands an experienced professional with strong management skills. Understanding of financial terms and principles. Ability to analyze complex data and develop innovative solutions. Translate ideas into deliverables. Make informed decisions when presented with conflicting information and opinions.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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