Job Description

Responsibilities : Understanding of key Pharmaceutical compliance regulations like Computerized System Validation, 21 CFR part 11, GxP, GAMP 5, SOX IT, Data Privacy, Data Integrity and Information Security Subject matter expertise in areas such as Quality Management, document management and Change Management Establish, implement and monitor the quality management requirements which assures that IT Projects meet Quality and Regulatory requirements Knowledge of Risk management perform root cause analysis on trends and address deviations via preventive, detective and corrective measures Knowledge and hands on experience conducting periodic or control maturity assessment and Audits Knowledge of various Validation tools and templates used throughout the Pharmaceutical industry Successful track record using Lean/Agile approaches to validate assets Proven ability in handling multiple large projects, respond quickly to changing situations in complex environments Minimum of 8+ years of professional experience in Life Sciences industry working for a consulting services organization and/or industry experience. Technical and Professional Requirements: Be responsible for the delivery of business results to global pharmaceutical, medical devices and pharmaceutical distributors. Serve as a team member, track lead or engagement lead on business consulting engagements for clients. Execute or lead consulting engagements in a global delivery model, working with consultants across regions. Lead / contribute to sales pursuits, consulting offerings and internal initiatives. Analyze problems, and structure complex business analyses. Perform Business Process Improvement using various business consulting tools and methodologies. Work with cross functional client teams to perform gap analysis and identify improvement options. Create detailed action plans that include organizational change management, resource planning, competitive strategies, and alliances to embark on a new strategic direction and to enable successful deployment of solutions.

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