CSV Validation Associate
Company: Beacon Hill Staffing Group
Location: Saint Paul
Posted on: April 18, 2024
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Job Description:
Position Summary: The Validation Associate will support the IT
environment with oversight responsibilities. Key
Responsibilities:
Author and review of validation packages and gap assessment of such
for deliverables received from vendors providing testing and
validation of internal SaaS systems
Management of the validation life cycle
Review and management of the various validation projects supporting
the GxP systems
Documentation, execution and review of testing required to meet the
intended use of the system
Maintenance of the validation documents in a controlled environment
and review at all times against inspection readiness compliant with
21 CFR Part 11, Annex 11 and other guidance and regulations
supporting CSV
Management and execution of system periodic reviews
Coordinate with various functions, business owners and IT to
maintain validated state of systems
Identify, plan and outline responsibilities for validation efforts
across GxP systems
Provide risk and impact assessments as required for change control
and system updates
Requirements:
Bachelor's degree (B.A./B.S.) or equivalent in computer science,
scientific or related discipline.
Experience, Expert Knowledge &/or Competencies:
7+ years related experience in Computer System Validation.
Knowledge of regulatory requirements and experience working in a
GxP and CSV requirements
Hands on experience in authoring validation documents and
associated procedures (SOPs)
Strong interpersonal verbal and documentation skills
Beacon Hill is an Equal Opportunity Employer that values the
strength diversity brings to the workplace. Individuals with
Disabilities and Protected Veterans are encouraged to apply. If you
would like to complete our voluntary self-identification form,
please click here or copy and paste the following link into an open
window in your browser: https://jobs.beaconhillstaffing.com/eeoc/
Completion of this form is voluntary and will not affect your
opportunity for employment, or the terms or conditions of your
employment. This form will be used for reporting purposes only and
will be kept separate from all other records. Company Profile:
Founded by industry leaders to set a new standard in search, career
placement and flexible staffing, we deliver coordinated staffing
solutions with unparalleled service, a commitment to project
completion and success and a passion for innovation, creativity and
continuous improvement. Our niche brands offer a complete suite of
staffing services to emerging growth companies and the Fortune 500
across market sectors, career specialties/disciplines and
industries. Over time, office locations, specialty practice areas
and service offerings will be added to address ever changing
constituent needs. Learn more about Beacon Hill Staffing Group and
our specialty divisions, Beacon Hill Associates, Beacon Hill
Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life
Sciences and Beacon Hill Technologies by visiting
www.beaconhillstaffing.com . We look forward to working with you!
Beacon Hill. Employing the Future---
Keywords: Beacon Hill Staffing Group, Woodbury , CSV Validation Associate, Other , Saint Paul, Minnesota
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