Data Integrity and Computer System Validation Consultant
Company: ADDASTAFF CONSULTING
Location: San Mateo
Posted on: May 12, 2022
View all jobs Data Integrity and Computer System Validation
Consultant San Mateo, CA Title: -Computer System Validation and
Data Integrity Consultant Type/ Location: -Contract/ San Mateo, CA
Overview: We are looking for a Computer System Validation and Data
Integrity Consultant for a Life Sciences client at San Mateo. The
position will work on driving Data Integrity policies, principles,
and collaborating with CMOs and other business. - Also, the person
will work with pharmaceutical partners and platform providers to
facilitate the development of remediation plans, training, and
support the execution of the plan. Deliverables and
- Design, perform Data Integrity risk assessments, write reports,
suggest remediation's in CGMP operations by having an understanding
of computer system validation, pharmaceutical manufacturing,
testing, supply chain process.
- Weekly monitoring of evolving regulations, FDA warning letters,
483's related to Data integrity, prepare trend reports to stay
current with "c"GMP regulations with the understanding of where
they can find this information, analyze and prepare executive
- Prepare metrics relevant to evolving citations and being
familiar with analytics tools like a spreadsheet, Microsoft
powerBI, Tableau will help us focus on the trends and associated
- 10-15 years of experience with Data Integrity programs (develop
new approaches, assessments, suggest remediation's/solutions in
cGMP operations preferred with pharmaceutical background)
- Good understanding of computer system validation and management
in cGMP operations.
- Strong at analytics (analysis of agency-related warning
letters, 483s, pattern recognition, prepare intelligence reports,
- Highly determined
- Ability to think through the task.
- Fast learner with evolving technologies.
Keywords: ADDASTAFF CONSULTING, San Mateo , Data Integrity and Computer System Validation Consultant, IT / Software / Systems , San Mateo, California
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