Infosys

Consultant - Business Consulting (Life Science - GRC/CSV)

Posted On

June 29, 2024

Location

Bangalore, Karnataka

Experience Level

5 - 12 Years Exp.

Job Type

Permanent

Apply By

Oct. 6, 2024

Job Description

Responsibilities: • 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. • 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. • Lead client workshops to collaborate with client employees and educate them throughout the process. • Participate in a variety of Firm building events and the consultant referral program. Educational Requirements Bachelor of Engineering Additional Responsibities: • Knowledge of various Validation tools and templates used throughout the pharmaceutical industry • Successful track record using Lean/Agile approaches to validate assets • Preferable IT background to understand larger impact of architecture / technical complexities on the program • MBA and/or Advanced degree (MS, MPH, PharmD and/or PhD) is preferred Technical and Professional Requirements: • 2 – 14 years of professional experience in Life Sciences industry working for a consulting services organization and/or industry experience. • 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 • Experienced in Validation of SAP / S4 HANA projects • Knowledge and hands on experience conducting periodic or control maturity assessment and Audits

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