CSV Consultant - Congers, NY (REF9259O)
Company: ProPharma Group
Posted on: May 13, 2022
ProPharma Group is an industry leading, single source provider for
regulatory compliance, pharmacovigilance, and medical information
services across the full development lifecycle for pharmaceutical,
biotechnology, and medical device companies. Operating around the
world with offices in Australia, Canada, Germany, Japan, the
Netherlands, Sweden, United Kingdom, and the United States,
ProPharma Group's fully integrated service offerings will provide
clients with a comprehensive suite of global support services that
are required to be competitive in today's dynamic markets. We build
successful long-term relationships with clients by providing
leading industry knowledge, experience, and proven processes.
Our client is in need of a CSV Consultant for a 6-month, on-site
engagement at their Congers, NY facility. Client is looking for a
CSV subject matter expert with intermediate level data integrity
experience. Roughly 15 systems to validate. Duties and
responsibilities to include, but are not limited to:
Obtain specific assignments from ProPharma Group or client Project
Ensure individual activities are clearly communicated and
documented to Project Manager.
Execute basic qualification protocols (IQ/OQ/PQ), document
deviations, and develop traceability matrices.
Review assigned protocols prior to execution.
Perform technical writing and communicate clearly on all technical,
business, and professional interpersonal levels of the
Apply Computer System Validation experience as it relates to GxP
regulated business processes.
Attend and contribute to scheduled Practice meetings.
Participate in company programs such as Project Management,
Quality, Social Responsibility, Wellness, Safety and Training.
Create annual personal goals and development plan with
Assist with interviews of ProPharma Group candidates.
Extensive travel required.
Other duties as assigned.
Qualified Candidates Must Have
B.S./B.A. in Engineering, Science, Information Technology or
Three years of relevant work experience may be substituted in lieu
Minimum 7-year experience in the field of Computer System
Minimum 7-year experience in related Pharmaceutical or Healthcare
Experience in the validation of at least one computer system
category: automation control, laboratory systems, quality workflow,
ERP, clinical data.
Possess effective written and oral communication skills; ability to
write, type, express or exchange ideas of a technical nature by
means of the spoken word; convey information/instructions
accurately; receive detailed information through oral or written
forms and to translate those instructions into physical execution
General business math skills.
Working knowledge of Microsoft Word, Microsoft Excel, and other
word processing programs as may be required by the position
(PowerPoint, Access and Microsoft Project may be required)
including but not limited to Visio.
Ability to walk, stand and move about for long periods of time;
work with equipment in the field, read, prepare and analyze data
for development of reports; ability to sit and type for long
periods of time; ability to read and assemble documents as
Basic knowledge of FDA GxPs, FDA Guidelines, and European
Guidelines (where applicable) and other regulatory
Basic knowledge of industry best practice such as GAMP5, ANSI
standards (S-95, S-88), and ASTM (E2500).
Basic knowledge of 21 CFR 11, including ERES, predicate rule and
legacy system requirements.
All candidates must be legally eligible to work in the United
We are an equal opportunity employer. M/F/D/V
***ProPharma Group does not accept unsolicited resumes from
recruiters/third parties. Please, no phone calls or emails to
anyone regarding this posting.***
Keywords: ProPharma Group, Yonkers , CSV Consultant - Congers, NY (REF9259O), Professions , Congers, New York
Didn't find what you're looking for? Search again!