Oferta pracy: Qualified Person Łódzkie

HAYS Poland

Jesteśmy międzynarodową Agencją Doradztwa Personalnego oferującą usługi w zakresie rekrutacji specjalistycznej.
Cechą, która wyróżnia HAYS jest unikalny system rekrutacji w oparciu o podział na wyspecjalizowane dywizje obsługujące poszczególne sektory rynku pracy.
Numer w rejestrze agencji zatrudnienia: 361

Stanowisko:

Qualified Person

Miejsce pracy: Polska, łódzkie, Łódzkie

Opis stanowiska:

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