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Job Title: Data Integrity Consultant

Location : NYC , Long Island, USA

Job Description - FDA - Data Integrity - Compliance Professional
• Understanding applicable guidelines and regulations such as FDA, GDPR and industry best practices to
manage risk and ensure compliance.
• Developing, maintaining compliance documentations such as policies, standards, information asset
register and procedures.
• Monitoring internal control effectiveness and recommend solutions for customer.
• Perform compliance checks such as internal audits and assurance for all Customer's regulatory
applications and maintain compliance as per MSA and Industry best practices.
• Ensures appropriate treatment of risk, compliance, and assurance from internal and external
perspectives.
• Oversee existing ServiceNow Change Management process and bring in Process Compliance into
Change Management Process.
• Support Internal Audit team in Site Audit Planning, Pre-Audit Readiness and in execution of audit
checklist across various Customer's sites.
• Review the current audit process and bring in process improvements and execute ownership in creation
of new procedures for the recommended process changes.
• Work with IT Data Stewards in collection and review of evidences for external audit.
• Create awareness through trainings for Application Owners and Data Stewards.
• Support Customer in the transformation from Computer System Validation to Computer Software
Assurance
• Execution of process changes, and trainings for Computer Software Assurance process controls.
• Identifies and formally documents deviations from published standards, estimates risk level,
recommends appropriate mitigation countermeasures in operational and non-operational situations.
• Handling audits for Internal, External units like ERM, GDPR and FDA regulatory audit areas.
Expected Professional Experience:
• Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based
Approach to Compliant GxP Computerized Systems.
• Should have detailed understanding of GxP environment and GAMP compliance.
• Work directly with IT teammates to ensure appropriate documentation for GxP systems is completed per
IT procedures.
• Working knowledge of FDA regulations and guidance particularly 21 CFR part 11, GAMP5.
• Perform gap analysis on current computer system to ensure compliance with 21 Part 11, Annex 11, and
applicable predicate rules.
• Exposure to Data Integrity requirements and other applicable regulations
• Generate and execute verification and validation (System Testing, IQ, OQ, PQ, UAT) documentation for
GxP and non-GxP computerized systems such as IT infrastructure, R&D (Pre-Clinical/Clinical, Medical
Affairs, Regulatory Affairs, Pharmacovigilance), Commercial (CRM, eCommerce), Supply Chain/
Manufacturing Operations / Quality (Labs, Labelling/Artwork, QMS, Change Management, Deviations &
Investigations, Training), Finance, HR, Legal/Corporate Compliance). Experience of agency regulations
(e.g., FDA 21 CFR Part 11, 211, 820; EudraLex Annex 11) and guidance (e.g., FDA, GPSV), and
industry best practices (e.g., ISPE, GAMP 5).
• Knowledge of validation of cGxP computerized systems within FDA regulated environments with a
strong understanding of industry standards and best practices for computer validation such as GAMP 5,
21 CFR Part 11, Annex 11, and applicable predicate regulations.
• Ensure all project and life cycle documents achieve the goal of traceability, and these are all retained in
the designated document repository (paper or electronic) and approved in accordance to the prescribed
SOPs.
• Effective written and oral communication skills.
• Proficient in Microsoft Excel, Word and PowerPoint including data visualization.
• Exposure to Internal and External Audits.
• Excellent time management, interpersonal and problem-solving skills.
• Must demonstrate the ability to excel in a collaborative teamworking environment.
Additional Preference(s):
• Understanding of quality risk-management concepts (ICH Q9)
• Understanding of ITIL Framework concepts (e.g., Incident, Problem, Change management processes)
• Information Security or Risk Management certification

Expected annual pay for this role ranges from $100000 to $127000. Based on the position, the role is also eligible for Wipro's standard benefits including a full range of medical and dental benefits options, disability insurance, paid time off (inclusive of sick leave), other paid and unpaid leave options.

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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