Computer System Validation Specialist
Company: Quality Chemical Laboratories
Location: Wilmington
Posted on: March 17, 2023
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Job Description:
Quality Chemical Laboratories (QCL), a leading Pharmaceutical
testing and manufacturing laboratory in Wilmington, is seeking a
qualified candidate for the position of Computer System Validation
Specialist.
Responsibilities:
Performs and leads computer system validation projects related to
authoring and executing validation documentation for laboratory
instruments/equipment and systems according to the ISPE GAMP 5
Validation Life Cycle. Documentation includes Computer System
Validation Plan, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary
reports, Requirements Traceability Matrix (RTM), Periodic Review of
Computer Systems, and Data Integrity Assessment.
Track and resolve deviations/exceptions during qualification
activities.
Work with company management to implement changes and upgrades to
computer systems
Work with vendors on purchasing and planning for new lab
equipment/software upgrades, review vendor protocols/design
specifications
Communicate Computer System Validation approaches and requirements
during audits.
Review validated systems to assess need for further enhancements,
validation, or system upgrades/fixes
Qualifications:
Two (2) years of experience with Computer System Validation in GxP
environment (preferably pharmaceutical industry).
Experience in writing computer system test scripts, validation
protocols and summary reportsKnowledge of Regulatory Requirements,
21CFR11, Data Integrity Guidance, GAMP and industry best practices
for validation to complete tasks
Proficient in analyzing and troubleshooting problems, identifying
solutions, recommending, and implementing methods, procedures
and/or techniques for resolution
Capable of managing multiple sub-projects, duties and tasks
Effective at communicating clearly and concisely, both orally and
in writing
Able to work both independently and as a member of a
cross-functional project team
Quality Chemical Laboratories (QCL) is a rapidly growing
pharmaceutical testing and manufacturing lab in Wilmington, NC. We
are seeking highly motivated candidates for multiple positions
throughout the company in the areas of analytical data review,
LabWare LIMS development/configuration/validation, Document
Control,Computer System Validation and Data Integrity Specialists,
Scientists (all levels) with experience in Mass Spec, LC, GC, QC
compendial testing, Wet Chemistry, Microbiology, Sterility,
Synthetic Chemistry, Biotech, Pharmaceutical Formulation and
Manufacturing (requires knowledge of manufacturing equipment),
Validation Engineers, Metrology, Report Generation, Sample Log-In
Associates, and HVAC Technicians. Special attention given to
candidates with an advanced degree in Chemistry or related science
and experience in method development/validation. Special
consideration also given to experienced GMP data reviewers.
QCL offers competitive salaries commensurate with experience and an
excellent benefits package, as well as great potential for career
advancement and leadership in a rapidly growing company.We now also
offer subsidized childcare at our newly acquired childcare
facility.For more information about our company and our available
positions, please visit our website @www.qualitychemlabs.com.
Qualified candidates should apply via our
websitewww.qualitychemlabs.comor email resumes
tohrassistant@qualitychemlabs.com.
Or click APPLY NOW to submit your resume today!
QCL is an equal opportunity employer.recblid
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Keywords: Quality Chemical Laboratories, Wilmington , Computer System Validation Specialist, Other , Wilmington, North Carolina
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