Johnson Service Group (JSG) is currently looking for Validation Lab Equipment Specialists. This is a long-term contracting opportunity with a world leading pharmaceutical company located in Albany, NY.
Hourly rate $60.00
Responsibilities:
Involved in Validating and Qualifying all Analytical Lab equipment and its associated technologies.
Perform and document vendor audits in identifying the lab Instruments.
Document, review, and approved 21 CFR Part 11 Assessment and GxP Data Integrity Risk Assessments.
Develop requirements that facilitate the hardware, software and vendor selection for the lab instruments and its associated software to be installed.
Responsible for the creation of qualification and validation programs (Equipment, automated systems, and Computer Systems) for the manufacturing site, the Quality Control (QC) laboratory, and facility support systems.
Validate analytical instruments-- Micro balances, Gas Samplers, Air Samplers, Autoclaves, Incubators, centrifuges, Evaporators, Plate Readers, HPLC, and associated software.
Develop Gap Analysis and Periodic Reviews.
Review FAT, SAT and User Acceptance Testing (UAT) documentation.
Documented IQ Protocols, OQ Protocols and PQ Protocols.
Develop standard methods for identifying the frequency of periodic review of lab instruments.
Develop Impact Assessments and Risk Analysis documents.
Develop Standard Operating Procedures and Work Instructions.
Develop Decommissioning Activities for various lab instrumentation.
Document Sampling Points during the Installation Qualifications.
Involved in developing Validation Plan, User and Functional Requirement Specifications, Summary Reports
Reviewed Process flows, Requirements Documents, Configuration documents and Design Specifications.
Partnered with Quality Assurance personnel to review and approve validation deliverables.
Involved in IQ, OQ, PQ test script preparation and test executions including deviations if any.
Worked with CAPA team to root cause of issues and preparation of deviation reports.
Developed/Maintained the Requirements Traceability Matrix (RTM).
Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.
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