J&J Family of Companies GMP certification specialist in Moscow, 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.

Qualifications

Education: Pharmaceutical / technological / chemical

Regulatory / Quality background, etc.

Experience: 2 or more years of experience in RA

Knowledge:

  • 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

Additional Requirements

  • English – upper intermediate

  • PC experience: MS Word – working level, MS Excel - basic

Primary Location

Russia-Moscow-Moscow

Organization

J&J LLC Russia (8431)

Job Function

Regulatory Affairs

Requisition ID

000019U7