Local Quality Representative BHC level

Descrierea postului:

Safety & Quality related issue management:
LQR is the responsible internal person for all Product Technical Complaints (PTC) and counterfeits that are received and/or discovered in the country.

Storage and transportation:
LQR is responsible to ensure that the local warehouse meet the appropriate quality standard and if necessary is in charge to ensure that a quality agreement exists.

Market Release:
LQR assures that the products are released fulfilling GMP demands and meeting regulatory compliances.

Local QA System:
LQR is responsible for establishing and fostering of the QA-Systems within the commercial operation (local QA-system has to be determinated).

Implementation of BHC GMP Directives (CMS):
LQR ensures the implementation of companies which are relevant for the sales organization.
LQR is responsible for the training of the staff regarding the applicable local SOPs and the training records are being held for review by external audit.

Cerinte
Qualified Person for Pharmaceutical Quality Control
- University Diploma or other university official qualification ( at least 4 years of study) in Pharmacy, Medicine, Veterinary Medicine, Chemistry, Biochemistry ( chemistry and pharmaceutical technology), Biology
- practical experience of at least 2 years (in a drug manufacturing unit, in activities of qualitative analysis of drug or quantitative analysis of active substances, other types of tests and validations for drug quality assurance.
- the duration of practical experience can of 1 year if the university qualification studies had a duration of 5 years and of 6 months if the university qualification studies had a duration of 6 years

Qualifications as required by National Medicines Agency
- very good knowledge of local and international laws, rules and regulations for pharmaceutical drug control and quality control
- fluent in English language
- basic knowledge in Pharmacovigilance and Regulatory affairs
- Personal Computer skills : office, word, excel, other specific programs
- Good relationship with Health Authorities - National Medicines Agency
- Good communication, skills and assertiveness
- expertise in audit for Good Manufacturing Practice, Good Distribution Practice
- knowledge of German language
- experience in same/similar position in/for a national/multinational pharma company