Coordonator Asigurarea Calitatii
Alatura-te unei companii farmaceutice si contribuie alaturi de o echipa de specialisti, la asigurarea calitatii si sigurantei medicamentelor.
Cautam un profesionist cu experienta in industria farmaceutica, care sa coordoneze si sa asigure activitatile de Asigurarea Calitatii aferente studiilor de bioechivalenta. Persoana va avea responsabilitatea de a supraveghea respectarea cerintelor de calitate, a protocoalelor si a reglementarilor aplicabile pe parcursul intregului proces, asigurand conformitatea studiilor si mentinerea standardelor GMP/GCP relevante.
Cerinte:
Experienta de minimum 5 ani intr-un rol de asigurarea calitatii (QA) in industria farmaceutica.
Experienta solida in activitati de asigurarea calitatii (QA) in mediul farmaceutic.
Experienta in gestionarea documentatiei de calitate, audituri si activitati de conformitate.
Capacitate de coordonare si monitorizare a proceselor pentru asigurarea respectarii protocoalelor si procedurilor interne.
Cunostinte privind studiile de bioechivalenta din industria farmaceutica.
Responsabilitati:
Coordoneaza si monitorizeaza sistemul de Asigurare a Calitatii pentru studiile de bioechivalenta si studiile clinice, in conformitate cu cerintele GCP, GMP, GPvP, ISO 9001 si reglementarile aplicabile.
Elaboreaza, revizuieste si aproba documentatia de calitate, procedurile si documentele specifice departamentului.
Planifica, coordoneaza si realizeaza audituri interne si ale studiilor clinice, urmarind implementarea masurilor corective si preventive (CAPA).
Coordoneaza evaluarea si calificarea furnizorilor implicati in studiile clinice.
Monitorizeaza conformitatea studiilor si integritatea datelor, inclusiv emiterea certificatelor de audit.
Asigura pregatirea pentru inspectii si obtinerea/mentinerea autorizatiilor si certificarilor relevante (GMP, ISO 9001).
Coordoneaza si dezvolta echipa QA, organizeaza instruiri si promoveaza imbunatatirea continua a sistemului de calitate.
Gestioneaza activitatea departamentului, inclusiv planificarea bugetului, raportarea rezultatelor si colaborarea cu echipele interne pentru asigurarea conformitatii.
- Department
- Pharma
- Locations
- Cluj-Napoca
About Sales Consulting
As a leading provider of Human Resources consulting services in Transylvania, we deliver regional coverage and specialized expertise across four core areas: recruitment and selection, personnel leasing, assessment centers and HR consultancy. With a strong and consistent presence on the Romanian market, we continue to consolidate our position through a strategic commitment to continuous improvement and alignment with evolving business needs.
Our success is founded on the professionalism of our services, the multidisciplinary capabilities of our consulting team, and the long-standing partnerships we maintain with clients who rely on our support in navigating complex HR challenges.
We collaborate with organizations across a broad range of industries, including IT&C, automotive, outsourcing, pharmaceutical, banking, FMCG and others, building sustainable, long-term relationships that contribute to their organizational growth.
Guided by the principles of client orientation, teamwork, flexibility, excellence, dedication, and responsibility, we remain focused on delivering measurable value and consistently high-quality services to our partners.