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.

Additional Responsibilities :

• 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

Preferred Skills :Technology->Life Sciences->Regulatory Systems,Technology->Life Sciences->Cloud based Regulatory SystemsEducational Requirements :Bachelor of EngineeringService Line :Infosys Consulting

Infosys