Job description
Overview:
Job title: GXP-Validation Analyst
Purpose of the position
Key responsibilities
Work experience & skills
About Wipro:
Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO) is a leading technology services and consulting company focused on building innovative solutions that address clients’ most complex digital transformation needs. We leverage our holistic portfolio of capabilities in consulting, design, engineering, operations, and emerging technologies to help clients realize their boldest ambitions and build future-ready, sustainable businesses. A company recognized globally for its comprehensive portfolio of services, strong commitment to sustainability and good corporate citizenship, we have over 250,000 dedicated employees serving clients across 66 countries. We deliver on the promise of helping our customers, colleagues, and communities thrive in an ever-changing world.
- A PROUD HISTORY OF OVER 75 YEARS
- FY22 REVENUE 10.4 BN USD
- WE’RE PRESENT IN 66 COUNTRIES
- OVER 1,400 ACTIVE GLOBAL CLIENTS
Job title: GXP-Validation Analyst
Location: Chicago, IL
Onsite
Rate: $40/hr
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
Wipro is an Equal Employment Opportunity employer and makes all employment and employment-related decisions without regard to a person's race, sex, national origin, ancestry, disability, sexual orientation, or any other status protected by applicable law.
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