Job expirat
• Follows compliance and implementation of quality policies and Quality Standards within R&D QA, Analytical Development Laboratory (AD), Product Development and Research Department (PDR) and Clinical Pharmacology and Pharmacokinetics Department
• Follows implementation and compliance with guidelines regarding Good Laboratory Practice, Good Clinical Practice, and Good Manufacturing Practice for medicinal products and investigational medicinal products.
• Assure that accelerated stability study protocols and test results in development (i.e., before Technology Transfer) are documented appropriately (justification of limits selected, statistical analysis for setting of impurity limits, adequacy of lab operations with respect to GMP requirements, etc.).
• Assure that all raw materials, excipients, etc., for the final formulation are approved and qualified.
• Assure that Technology Transfer Dossiers up to Development Stage are reviewed adequately within the team to verify scientific rigor, adequacy, and completeness.
• Prepares and reviews R&D QA specific SOPs, reviews and approves AD, PDR and CPP Department specific SOPs.
• Performs Internal Audits within Analytical Development Laboratory and Product Development and Research Department according to Internal Audit Schedule. Performs Internal System Audits and Study based audits within CPP department according to Internal Audit Schedule and Study Specific Audit Program
Master in Pharmacy / Master in Chemistry or equivalent .
Fluent in English (written and spoken).
Industry work experience : 1-3 Years - Content areas: medicinal products QC testing,GMP and method validation knowledge is an advantage .
MS Office - advanced user
Infiintata in 1921, Terapia reprezinta o garantie a calitatii prin traditie, un nume de marca care a inregistrat constant cresteri si profitabilitate.
In prezent detine o retea de distributie care constituie cea mai mare forta de vanzari din piata farmaceutica, un excelent departament de cercetare si dezvoltare, un modern centru de bioechivalenta, importante centre de productie conform regulilor de buna practica de fabricatie in Cluj-Napoca si Bucuresti. Insumand peste 1000 de angajati in total, Terapia reprezinta cea mai mare achizitie Ranbaxy de pana acum.
Ranbaxy Laboratories Limited este o companie multinationala farmaceutica integrata axata pe cercetare. Compania are sediul central in India si este clasata in topul primelor 10 companii producatoare de produse farmaceutice generice, fiind prezenta in 23 dintre cele 25 de state ale lumii, reprezentative ca piete in domeniul farmaceutic.
Ranbaxy are sedii in 49 de tari si 11 centre de produtie, indreptandu-se rapid catre o pozitie de top in lume, bazandu-i succesul pe o pozitionare solida in piete consacrate in domeniu sau dimpotriva aflate in prezent in dezvoltare.
In iunie 2006, Ranbaxy Laboratories Limited a preluat pachetul majoritar de actiuni al TERAPIA - astfel am devenit
Cea mai mare companie producatoare de produse farmaceutice generice din Romania
Doresti sa-ti construiesti o cariera intr-o companie unde gasesti mediul cel mai potrivit pentru dezvoltarea ta si unde poti intalni toate ingredientele care sunt importante pentru tine ca sa fii multumit si implinit pe plan profesionala?
Alege PROVOCAREA, alatura-te echipei TERAPIA RANBAXY, iar noi te asiguram de suportul nostru continuu pentru dezvoltarea ta ulterioara!
http://www.terapia-ranbaxy.ro
