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CSV (Tech Writter)

  • Job type: Contract
  • Location: Norwood, Massachusetts
  • Salary: Negotiable
  • Job reference: 302241/001_1555431241
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 16/04/2019

Currently there is an immediate opening for a CSV Professional at a biotech company that focuses on innovative medicines across several therapeutic areas. The right candidate will have background experience with SLDC and change control.

You will be joining a fast growing and innovative company who invest in their people and resources, open organization with a transparency so seeking someone that is looking for someone very crossfuntional with great communication skills. If you have experience with Computer System Validation, SOP, QA/QC and has great communication skills for presentation then I'll be happy to further connect and discuss.

Role: CSV Technical Writer

Location: Boston-Cambridge-Norwood, MA

Qualifications and Skills

Requirements:

  • Bachelor's Degree in a scientific background or another relevant academic discipline.

  • At least 2-6 years of industry experience designing, implementing, and supporting compliance systems in FDA regulated industry.

  • Familiar with cGxP, 21 CFR Part 11, Annex 11, GAMP 5 is highly desirable.

  • GAMP 5 knowledge is highly desirable.

  • Experience with SDLC methodologies in a cGxP regulated environment

If you are interested in being considered for this role, submit your resume as soon as possible as they are moving fast!