Regulatory Compliance Intern

2 settimane fa


Ferentino, Lazio, Italia Thermo Fisher Scientific A tempo pieno

Summary of Internship


Internship positions provide an opportunity for chemistry, biology, engineering, pharmacy, or related STEM students to get hands on experience in the Regulatory Affairs and Compliance function.

Internship opportunities to build Regulatory Compliance Competence in key areas:

  • Regulatory Compliance Framework and Strategy
  • Business Acumen

Essential Functions:

  • Become familiar with FDA and EU regulations regarding requirement to maintain and update ML for sterile product's
  • Collaborate with team members for client's audit to assure compliance of the company procedures to current regulations (legislations, guidelines as GMP, FDA, etc.) and to compliance of Corporate policies
  • Support the team member in manage supplier qualification by questionnaire
  • Contribute to the guarantee the regulatory compliance of API, excipients, primary pck, GMP materials and prepare vendor quality agreements
  • Support in the preparation of KPI and periodical regulatory compliance trend

Qualifications:

  • Pursuing a Bachelor's degree
  • 0+ years of experience preferred
  • Preferred majors: Chemistry, Biology, Microbiology, Engineering, Pharmacy, Biochemistry
  • Strong desire and motivation to develop a career in regulatory compliance
  • Critical thinker with organization skill and attention to detail
  • Ability to work independently and as a member of a multifunctional team
  • Ability to learn, be mentored, and improve
  • Willingness to communicate across crossfunctional teams


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