Futran Tech Solutions Pvt. Ltd.
GXP-Validation Analyst
Futran Tech Solutions Pvt. Ltd., Chicago, Illinois, United States, 60290
Job title: GXP-Validation Analyst;
Location: Chicago/Nearshore CST time
PURPOSE OF THE POSITION
Consult project/client needs wrt validation and 21 CFR Part 11 GXP compliance testing proceduresPerforming Compliance evaluation of procedures and systems wrt equipment, facilities and computerized systems used in GLP, GMP and GCP 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 deliverablesUsing 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 systemsDirect and train staff on regulatory requirements, quality management processes and procedures, and inspection readinessConduct periodic assessment activities to ensure systems are operating in a compliant state and foster continuous improvementCollaborate with functional teams to ensure that the integrity of data and information is maintained throughout its lifecycleQuality Assurance/AuditsCommensurate with expertise, plan and conduct internal and external audits of technology in use by customer and tool vendors providing computing servicesGuide functional teams through the deviation/CAPA process to ensure robust investigation, timely action, and meaningful improvements to processUsing quality management system tools, analyze audit findings and deviation trends to drive continuous improvementCollaborate 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 systemConduct or participate in Mock Regulatory Inspection activities and/or provide guidance to functional teams to facilitate inspection readinessSpecial Projects, Other Responsibilities as assignedWORK EXPERIENCE & SKILLS
Familiarity with GxP systems (POMSnet, Maximo, OSI PI, SampleManager, 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, etcExcellent 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 / Master's 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 advantage
Location: Chicago/Nearshore CST time
PURPOSE OF THE POSITION
Consult project/client needs wrt validation and 21 CFR Part 11 GXP compliance testing proceduresPerforming Compliance evaluation of procedures and systems wrt equipment, facilities and computerized systems used in GLP, GMP and GCP 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 deliverablesUsing 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 systemsDirect and train staff on regulatory requirements, quality management processes and procedures, and inspection readinessConduct periodic assessment activities to ensure systems are operating in a compliant state and foster continuous improvementCollaborate with functional teams to ensure that the integrity of data and information is maintained throughout its lifecycleQuality Assurance/AuditsCommensurate with expertise, plan and conduct internal and external audits of technology in use by customer and tool vendors providing computing servicesGuide functional teams through the deviation/CAPA process to ensure robust investigation, timely action, and meaningful improvements to processUsing quality management system tools, analyze audit findings and deviation trends to drive continuous improvementCollaborate 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 systemConduct or participate in Mock Regulatory Inspection activities and/or provide guidance to functional teams to facilitate inspection readinessSpecial Projects, Other Responsibilities as assignedWORK EXPERIENCE & SKILLS
Familiarity with GxP systems (POMSnet, Maximo, OSI PI, SampleManager, 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, etcExcellent 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 / Master's 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 advantage