Municipiul Cluj-Napoca, Str. EMIL RACOVIŢĂ, Nr. 60/A, Etaj 1 si M
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Database Administrator / Business Analyst
expirat: 05.04.2023
Middle (2-5 ani), Senior (5-10 ani)
Salariu confidențial
Anunțuri Arhivate
Anunțuri Arhivate
QP & RP Manager
Cluj-Napoca
expirat: 05.11.2022
Senior (5-10 ani)
Atribuțiile:
Performing QA tasks and QP duties for product release of commercial human medicinal samples. The aim is that the manufacturing authorization is fully compliant with GMP legislation and other applicable rules. The QP role is to offer permanently and continuously the services of at least one Qualified Person
Refers to KBArt. 84-86
Must comply with the qualifications and conditions as presented in guideline of 7 March 2013 on GDP of medicinal products for human use (2013/C– revised on 5 NovemberCand in the RD of 14 Dec 2006 concerning medicinal products
Must be available at any time, when needed
May delegate tasks to other qualified (trained appropriately) personnel but remains end-responsible for the delegated tasks
Must make decisions, without being influenced, by other personnel of the company in relation with GDP-related activities
Must receive the necessary support, resources, and responsibilities from the general manager to be able to execute the GDP RP responsibilities
Reports directly to the general manager
Ensure good and correct, open communication towards the Inspectorate (FAMHP)
Must guarantee at all times that all GDP requirements are respected
Must guarantee the set-up, implementation, and continuous review of the Quality Management System (QMS)
Ensure trainings of personnel are executed on the QMS and GDP requirements, and that re-trainings are performed on a regular base or ad-hoc, when required
Coordinate and execute recalls, whenever needed
Handling of complaints
Supplier qualification and approval of suppliers
Approval of any outsourced activities, which could have an impact on GDP activities
Perform self-inspections on regular base, execute internal and external audit plans
Evaluate Deviations, CAPA management and ensure CAPA’s are timely executed
Take final decisions on returned goods, damaged goods, recalled goods or falsified goods
Handle returned goods in a correct way
Ensure that any additional requirement will be implemented in the company
Perform Yearly Management Review in an objective way
Perform Risk Assessments and put CAPAs in place
Ensure FEFO and check on a regular base the expiry dates of goods in warehouse