Job expirat
Set Quality Assurance goals and objectives in alignment with site Quality goals.
Organize, coordinate, plan and monitor the activities of subordinate department. Establishes department goals and priorities for the optimal activity.
Ensure and monitor the implementation and compliance with quality assurance system
Ensure compliance with global quality policy, company quality standards and Regional quality procedures.
Participation at the Site Quality System Management Review (SQSMR) and GQSMR meetings.
Ensure and monitor the implementation of Good Manufacturing Practice (GMP) for medicinal products, the Principles of Good Laboratory Practice (GLP), the Rules of Good Wholesale Distribution Practice (GDP) and Rules of Good Practice in Clinical Trials (GPCT).
Provide staff training regarding GMP, GLP, GDP, GCP.
Ensures compliance with Competent Authority requirements and with own procedures for resolving complaints of quality.
Ensure documentation for manufacturing authorizations and for request certification of GMP, GLP, and GCP.
Perform self-training and permanent informing related to legislation (laws, governmental decisions, emergency ordinances, special regulations, decisions of the Scientific Council of the National Agency for Medicines, etc.) Inform the departments concerned and verify the compliance.
Provide ongoing staff training referring GMP, GLP, GWP, GPCT and regularly evaluation of staff training.
Other activities according to job description.
Minimum Master’s Degree in Chemistry, Pharmacy or relevant scientific field; Ph.D preferred
10-15 years experience in pharmaceutical industry, quality systems, in line with the regulatory EU/US FDA requirements,
General understanding of the European and Romanian legislation and interpretation of EU GMP guidelines.
Understanding of pharmaceutical manufacturing, packaging, quality assurance, quality control, and regulatory affairs operations;
ADECCO RESURSE UMANE SRL
Romania, Bucuresti, sector 1, str. Dr. Iacob Felix Nr. 28, Etaj 4
Nr. ORCB J40/12364/2003, CUI RO15739037
Capital social subscris si varsat: 392.440 Lei
Nr. autorizatie Agent de Munca Temporara: 17/2005
Autorizatie seria nr. B/ 0000008/25.10.2005
Nr. Operator Date Personale: 15866
Tel: 00 40 21 300 35 46, Fax: 00 40 21 300 35 54
E-mail: office@adecco.ro, Web: www.adecco.ro
ADECCO ROMANIA SRL
Romania, Bucuresti, sector 1, str. Dr. Iacob Felix Nr. 28, Etaj 3
Nr. ORCB J40/4467/2000, CUI RO 13002186
Capital social subscris si varsat: 360.575 Lei
Nr. Operator Date Personale: 15862
Tel: 00 40 21 300 35 46, Fax: 00 40 21 300 35 54
E-mail: office@adecco.ro, Web: www.adecco.ro
BUCURESTI (HQ)- Doctor Iacob Felix Nr. 28, Sector 1, Tel.: 021/300 35 46; e-mail: recrutare@adecco.ro
ARAD - Mihai Eminescu nr. 45, Tel: 0257 / 281 147; E-mail: arad@adecco.ro
BRASOV - Str Petru Rares Nr 10; Tel.: 0040 - 372/70.57.95; e-mail: brasov@adecco.ro
CLUJ - Str. Vasile Lupu Nr 36 , Tel: 0264/ 406 234; e-mail: cluj@adecco.ro
IASI - Bld. Tutora Nr. 4, bl. B4 scara D, Tel: 0232 / 206 120; e-mail: iasi@adecco.ro
ORADEA - Str. Tudor Vladimirescu Nr 26; Tel.: 0040 - 727 735 160 e-mail: oradea@adecco.ro
PITESTI - Str. Fratii Golesti Nr. 57, etaj 2; Tel: 0248 / 612 303; e-mail: pitesti@adecco.ro
PLOIESTI - Str Mercurului Nr 1, Tel: 0244/ 519 320; e-mail: ploiesti@adecco.ro
SIBIU - Str. Vasile Milea Nr 11, Ap 57, Tel: 0269 / 206 450; e-mail: sibiu@adecco.ro
TIMISOARA - Str. Popa Sapca Nr. 12 tel: 0256/ 432 211; e-mail: timisoara@adecco.ro
