GXP-Validation Analyst

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 procedures
• Performing 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 zone

KEY 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 assigned

WORK 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, 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 / 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