sharing the costs of sports activities
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Oferta pracy
Quality Assurance Specialist - Patient Recruitment and Management
Medicover Integrated Clinical ServicesAbout the company
- WarszawaWarszawa, Masovian
- offer expired 2 years ago
- contract of employment
- full-time
- specialist (Mid / Regular)
- home office work
Your responsibilities
- Review patient medical records and patient databases;
- Ensure Qualification and QA/C oversight of affiliate and outsourced vendors involved in the provision of MICS PRM services through all phases of their service provision to MICS.
- Maintain up-to-date knowledge of FDA, ICH, EU and other country specific regulations and guidelines.
- Ensure the quality & compliance of MICS processes and business activities with respect to internal procedures as well as all applicable guidelines, regulatory requirements and country specific regulations.
- Perform vendors audits and ensure inspection readiness and serve as a key participant in third party audits and regulatory inspections.
- Participate in the periodic review of MICS Quality Management System Review for the PRM business pillar.
- Mange the deviations/investigations, Out of Specifications, CAPAs, change control, service complaints, recall, and risk’ assessments in compliance with internal procedures.
- Ensure all processes contributing to the performance of a clinical trial in all PRM units are conducted in accordance with ICH guidelines, GCP and all other regulations.
- Perform all quality assurance activities in the PRM units.
- monitor all main processes in MICS PRM units by performing audits, analyzing nonconformities and implementing corrective actions.
- interpret quality philosophy to key personnel in organization
- administrate together with QAD and the entire MICS QAU all quality system documentation: SOPs, instruction, forms.
- attend and respond for external audits;
- prepare training program for MICS PRM units personnel and arrange the trainings.
- perform other related duties and tasks as necessary or as assigned.
Our requirements
- Education: Master degree, at least 5 years of relevant experience in medical trials, laboratory practice is essential, minimum 1 year of experience in QA field and/or education in Quality Management.
- Language Ability: English - fluent, other languages as an option. Ability to read, analyze, and interpret common scientific and journals, financial reports, and legal documents. Ability to response to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format.
- Math Ability: Ability to understand and apply medium level mathematical concepts, functions, calculate indicators and analyze data from different software’s and sources.
- Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.
- Computer Skills: To perform this job successfully, an individual must have working knowledge of Microsoft Office applications including word processing software, spreadsheet software, PowerPoint, and MS Project
- 30% business travels
What we offer
- Stable employment;
- Support for ongoing projects;
- Cooperation with a well-coordinated and friendly team;
- Work in a Center that maintains high standards.
Benefits
- private medical care
- sharing the costs of professional training & courses
- life insurance
- corporate products and services at discounted prices
Job Summary
- Support the MICS QA Unit towards implementation of the MICS Quality vision and mindset of the entire company in close collaboration with the QAD and executive leadership team to the Patient Management Units;
- Ensure fulfilment of the Quality objectives and ensure progress and cross-functional completion of responsibilities;
- Oversee aspects of Quality related to MICS PRM Business Line services;
- Provide leadership, guidance, and direction to staff consistent with all applicable regulatory and industry standards;
- Support other functional management as they relate to quality operations;
- Ensure all processes contributing to the performance of a clinical trial are conducted in PRM units in accordance with ICH GCP guidelines and all other applicable regulatory requirements;
- Ensure compliance with the agreements with clients;
- Develop, perform and manage all Quality Assurance related activities such as internal auditing and the development of Quality Management Systems.
- Improve patient related activities outcomes.
- Ensure the medical facilities adhere to all relevant state, and local laws and regulations.
Medicover Integrated Clinical Services
Jako firma o europejskim zasięgu, wchodząca w skład międzynarodowej sieci Laboratoriów Medycznych oraz Punktów Pobrań, na polskim rynku jesteśmy obecni już od przeszło dwudziestu lat. Świadczymy kompleksową usługę w zakresie ogólnej i specjalistycznej diagnostyki laboratoryjnej (od prostych badań diagnostycznych, po zaawansowane badania kliniczne), a także w zakresie obsługi Pacjenta w zakresie pobrań materiału do badań.
Jesteśmy organizacją, która stawia na nowoczesne rozwiązania, stale rosnącą w siłę. Z niezwykłą dynamiką poszerzamy swoje portfolio klientów, rozbudowujemy swoją sieć. Naszą największą wartością są ludzie, bez których nasz sukces nie byłby możliwy. Każdego dnia kreujemy przyjazną atmosferę w pracy, inspirujemy, integrujemy zespoły. Cechuje nas ogromna uważność na potrzeby naszych pracowników, dlatego stawiamy na regularne spotkania, podczas których możemy usłyszeć głosy swoich pracowników.
Jeśli podzielasz nasze wartości i jesteś zainteresowany pracą w ciekawym środowisku medycznym, zaaplikuj na to stanowisko.
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Quality Assurance Specialist - Patient Recruitment and Management, Warszawa