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Role:GXP-Validation Analyst Location:Chicago, IL (Onsite)Purpose of the position Consult project/client needs wrt validation and 21 CFR Part 11 GXP compliance testing procedures Performing Compliance evaluation of procedures and systems wrt equipment, facilities and computerized systems used in GLP, GMP and Google Cloud Platform environments. Coordinate with cross-functional project teams in for deliverables within the agreed timeline. Support development of best practices within the validation group, based on current industry practices and guidelines. Required to be on the site in Chicago, IL or nearshore supporting Chicago time zoneKey responsibilities Serve as quality representative and compliance resource, directing the application of company standards for internal validation activities, including quality review and approval of project deliverables Using in-depth professional knowledge, provide guidance to employees, external contractors, clinical investigators, and development partners on complex topics related to computer system regulatory requirements, data integrity, and quality systems Direct and train staff on regulatory requirements, quality management processes and procedures, and inspection readiness Conduct periodic assessment activities to ensure systems are operating in a compliant state and foster continuous improvement Collaborate with functional teams to ensure that the integrity of data and information is maintained throughout its lifecycle Quality Assurance/Audits Commensurate with expertise, plan and conduct internal and external audits of technology in use by customer and tool vendors providing computing services Guide functional teams through the deviation/CAPA process to ensure robust investigation, timely action, and meaningful improvements to process Using quality management system tools, analyze audit findings and deviation trends to drive continuous improvement Collaborate with external contractors conducting audits on behalf of customer. This may include co-auditing activities, providing information about company processes, known quality issues, audit scoping expectations, and/or guidance on use of the audit system Conduct or participate in Mock Regulatory Inspection activities and/or provide guidance to functional teams to facilitate inspection readiness Special Projects, Other Responsibilities as assignedWork experience & skills Familiarity with GxP systems (POMSnet, Maximo, OSI PI, Sample Manager, Empower, Trackwise, ComplianceWire, Antares, Warehouse Serialization Solution, Discoverant) Experience with Kneat (App Change Management), qTest (ALM), & Tosca (automated testing) Knowledge of FDA and European compliance regulations and GAMP guidelines applicable to computer system validation. Familiar with off-the-shelf, configurable, and custom-developed applications validation. Experienced with various technologies and automated systems used in the pharmaceutical industry - Business System (ERP etc), Quality System (Track wise, LIMS etc), PLC or SCADA, Process Control, Laboratory Instrumentation, Data archive/historian, etc Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.Academic & trades qualifications Bachelor's degree in engineering / Masters Degree in science. Total 5 years of relevant validation testing experience with a minimum of 3 years or more experience in Validation testing. Experience in pharmaceutical/biotech manufacturing or testing is an added advantageThanks & Regards,A Certified (MBE) Minority Business Enterprise5755 North Point Parkway, Suite 79, Alpharetta, GA -30022Soumya KResourcing SpecialistP:+1 & EXT-250E: Please consider the environment before printingWe respect your online privacy. If you would like to be removed from our mailing list please reply with "Remove" in the subject and we will comply apologize for any inconvenience caused. Please let us know if you have more than one domain. The material in this e-mail is intended only for the use of the individual to whom it is addressed and may contain information that is confidential, privileged, and exempt from disclosure under applicable law. Ifyou are not the intended recipient, be advised that the unauthorized use, disclosure, copying, distribution, or the taking of any action in reliance on this information is strictly prohibited. We are an equal opportunity employer with a diverse workforce.