J&J Family of Companies GMP certification specialist in Москва, Russia
GMP certification specialist is responsible for execution of all activities concerned with mandatory GMP certification of the manufacturing sites by Russian Authorities.
Responsible for leading GMP projects: ensure an efficient cooperation with all local and global colleagues’, external communications with CMO, MoIT and of FSI «SID&GP».
Have deep knowledge of local legislation and requirements on GMP certification (Russian and EAEU) and have understanding of relevant international guidelines and practices.
Sharing experience and getting insights with colleagues from another companies, pharmaceutical associations, contribute in environment and legislation shaping via pharmaceutical associations membership.
Требования к кандидату
Education: Pharmaceutical / technological / chemical
Regulatory / Quality background, etc.
Experience: 2 or more years of experience in RA
Strong project management, problem solving and negotiating skills
Able to make independent decision
Multitasking, accurate and conscientious
Expertise in GMP requirements established in Russia & CIS and WW
Expertise in the inspection conduction
Ability to build strong relationship with Authorities
Result oriented team player
Analytical skills, strategic thinking;
Ability to work effectively in multi-functional project teams and to play under environment’s influence
Communication skills (negotiation skills in English & Russian)
Readiness for excessive travelling
English – upper intermediate
PC experience: MS Word – working level, MS Excel - basic
J&J LLC Russia (8431)