Qualified Person
Your new company We are looking for a Qualified Person for our pharmaceutical partner company in Komárom.
Your responsibilities
Ensuring the effective legislation requirements of manufacturing pharmaceutical products are fulfilled during the manufacturing, packaging, testing and handling of the medicinal products.
Certifying the finished product batch before release for sale in the EU/EEA. Ensures the medicinal product meets the requirements of the Marketing Authorization.
Certifying the partial manufacturing activity if the final certification site is not Mylan Hungary.
Approving suppliers that are relevant from GMP point of view; Participates in supplier audits.
Ensuring that any deviations/non conformances are investigated and reported. Participates the evaluation and approval of these reports.
Ensuring that the manufacturing and packaging are done on qualified equipment with validated procedures. Ensures the testing of products is done by validated procedures.
Reviewing deviations or changes in packaging, in quality control and in all the other departments of the QA system of Mylan Hungary to ensure that the records and changes have been authorized by the persons responsible in accordance with the quality system.
Taking part in Health Authority inspections, internal and self-audits. Reviews and approves the reports or notes of audits and inspections.
What you need to succeed
Profound knowledge of GMP guidelines and hosting GMP inspections. Must possess knowledge of all applicable regulated agencies that govern the industry. Must possess expert-level knowledge of Quality practices, processes and procedures.
Accuracy, attention to details. The jobholder must demonstrate integrity- strict adherence to rules and pharmaceutical regulations. Decision making and problem solving. Ability to transfer his knowledge to others.
Jobholder must possess M. Sc. in Life Sciences (Pharmacist, Chemical or Biological Engineer)
Must have at least 1 years of working experience at pharmaceutical company. Experience at a packaging site is preferred.
At least C1 level of local language (Hungarian) and English.
What you can expect from our partner
Annual salary increase depending on performance
Guaranteed immediate payment after successful completion of the trial period
Annual bonus
Travel subsidy
Company car for own usage too
Free company bus services
Rent cost contribution in the first 3 years
Monthly sports support
Life and accident insurance
Private specialist and diagnostic care
What you need to do now
In case you find this opportunity interesting, press on the ’Apply’ button and send us your fresh CV.
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