Job expirat
Marea Neagrǎ Medical Srl is a newly established pharmaceutical 3rd country importer, trader & parallel distributor near the ring road of Bucharest.
We are presently in search of a qualified person (QP) with regulatory experience to assist us in obtaining and maintaining GDP & GMP licenses as well as marketing authorizations.
As Qualified Person you will be responsible for filing of applications and communication with the Romanian Agentia Națională a Medicamentului as well as other European medicinal authorities on behalf of the company.
You will also be responsible for SOP development, GMP training of other staff members as well as maintaining the quality manual of the company.
Qualifications Required :
● Science graduate in pharmacy or chemistry
● Previous experience of 3-8 years as qualified person (QP)
● Reasonable experienced in quality assurance of GDP/GMP as well as to build-up & maintain a quality management system
● Fluency and proficiency in both written and spoken English
● Ability to work individually as well as in a team