Person2Person, LLC
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| IT Quality Validation Consultant Based in North Carolina |
| Outstanding Contract opportunity with a global pharmaceutical Company focused on multiple therapeutic areas including Neurology, Oncology and Critical Care. They continue to move forward with an entry into biologics with the development of therapeutic antibodies and other such agents, which contributes to their innovate drug discovery process. Be a part of this global market leader! |
| SCOPE & DUTIES |
Review and perfect SDLC and SQA documentation to Company standards and recommend corrections for
regulatory compliance. Update IT operations and procedures for improved quality attributes. Evaluate
the validation state of applications and assist with bringing excursions back into compliance. Collect and
process information for IT Quality metrics. Assist with implementing IT Quality-related system
improvements.
regulatory compliance. Update IT operations and procedures for improved quality attributes. Evaluate
the validation state of applications and assist with bringing excursions back into compliance. Collect and
process information for IT Quality metrics. Assist with implementing IT Quality-related system
improvements.
| REQUIREMENTS |
1) Extensive experience (10 years) with manufacturing and quality applications
and automation systems in pharmaceutical manufacturing facilities
2) Experience (7 years) with FDA cGxPs, 21 CFR Part 11, EMA Annex 11, PIC/S
computerized systems validation, and GAMP 5, as well as their application
to preparing defensible validation documentation
3) Experience (5 years) with determining defensible SDLC and SQA approaches
to varied types of IT-related computerized systems
4) Excellent writing and communications skills
5) BS Degree required, Masters or above preferred
and automation systems in pharmaceutical manufacturing facilities
2) Experience (7 years) with FDA cGxPs, 21 CFR Part 11, EMA Annex 11, PIC/S
computerized systems validation, and GAMP 5, as well as their application
to preparing defensible validation documentation
3) Experience (5 years) with determining defensible SDLC and SQA approaches
to varied types of IT-related computerized systems
4) Excellent writing and communications skills
5) BS Degree required, Masters or above preferred
| Executive Recruiting Specialists in the NY/NJ/CT Region |
Apply today! For immediate consideration, please email resume to: lsydor@person2personllc.com |