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Qualified Person

QP, qualified person, OW, osoba wykwalifikowana, English, angielski
Main responsibilities:
  • Act as a Qualified Person (QP) for the Importer Warehouse according to the Polish regulations,
  • Batch certification and marketing release of medicinal products (sterile and non-sterile, biosimilars)
  • Supporting operations in Importer Warehouse (GMP) according to polish pharmaceutical law and GMP rules (Importing/ Storage/Retain samples / Release/ Data logger -Temp excursion management / ADRs / Export to Non-EU countries)
  • Supporting Quality Systems, processes and procedures
  • Set up SOPs according to company’s SOPs
  • Participation in the supervision of compliance with GMP rules in organizational units affecting the quality of medicinal products (Importer's Magazine)
  • Participation in internal and external audits
  • Participation in the preparation of production areas for inspections and audits
  • Participation in process validation processes, equipment qualification, premises, systems in accordance with GMP requirements
  • Cooperation with quality control laboratories responsible for series control
  • Verification of batch documentation, quality assessment of products
  • Participation in annual reports approval on the Product Quality Review
  • Participation in the development, verification and approval of quality agreements
Expectations:
  • Higher education (pharmacy preferred faculty), medical analytics, biology, biotechnology, chemistry, medicine, veterinary medicine) - a prerequisite
  • Min. 3 years of experience working in a similar position in a pharmaceutical company (sterile and non-sterile)
  • Experience at the company, of the holder of the manufacturing or import license in the areas of analysis, studies or audit activities related to the assessment of medicinal products and the conditions in which they are manufactured;
  • Qualified Person QP status;
  • Pharmaceutical Development experience is an advantage;
  • Excellent Knowledge of current regulations for quality systems, GMP procedures and compliance;
  • Experience in providing technical advice and support in the preparation of Technical Agreements to the Contracts and Proposals group;
  • Internal and external audits experience
  • Very good communication in English in writing and speaking,
  • Commitment, responsibility and an ambitious approach to tasks
  • Collaboration skills in a team
  • Very good knowledge of the MS Office package
We offer:
  • International and dynamic working environment
  • Employment based on an employment contract
  • Opportunity to grow professionally within organisation
  • Training to raise qualifications
  • Work tools suitable for the workplace and job position
  • Attractive benefits package

Hays Poland sp. z o.o. is an employment agency registered in a registry kept by Marshal of the Mazowieckie Voivodeship under the number 361. #1170266
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Summary

Job Type
Permanent
Industry
Pharmaceuticals
Location
Łódzkie
Specialism
Pharma
Ref:
1170266
Closing date
31 Mar 2023

Talk to a consultant

Talk to Aleksandra Figielska, the specialist consultant managing this position, located in Warszawa
Hays, ul. Marszałkowska 126/134

Telephone: 722000702

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