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: 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 documentation such as policies, standards, information asset register and procedures.
- Monitoring internal control effectiveness and recommending solutions for customers.
- Performing compliance checks such as internal audits and assurance for all Customer’s regulatory applications and maintaining compliance as per MSA and industry best practices.
- Ensuring appropriate treatment of risk, compliance, and assurance from internal and external perspectives.
- Overseeing existing ServiceNow Change Management process and integrating Process Compliance into Change Management Process.
- Supporting Internal Audit team in Site Audit Planning, Pre-Audit Readiness and in execution of audit checklist across various Customer’s sites.
- Reviewing the current audit process and recommending process improvements and executing ownership in creation of new procedures for the recommended process changes.
- Working with IT Data Stewards in collection and review of evidences for external audit.
- Creating awareness through trainings for Application Owners and Data Stewards.
- Supporting Customer in the transformation from Computer System Validation to Computer Software Assurance.
- Executing process changes, and trainings for Computer Software Assurance process controls.
- Identifying and formally documenting deviations from published standards, estimating risk level, and recommending 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.
- Detailed understanding of GxP environment and GAMP compliance.
- Working 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.
- Performing gap analysis on current computer systems to ensure compliance with 21 Part 11, Annex 11, and applicable predicate rules.
- Exposure to Data Integrity requirements and other applicable regulations.
- Generating and executing verification and validation (System Testing, IQ, OQ, PQ, UAT) documentation for GxP and non-GxP computerized systems.
- Knowledge of validation of cGxP computerized systems within FDA regulated environments with a strong understanding of industry standards and best practices for computer validation.
- Ensuring all project and life cycle documents achieve the goal of traceability, and these are all retained in the designated document repository and approved in accordance with 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 $100,000 to $127,000. 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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