Job Description

Responsibilities :What are we looking for?Analysts, Consultants, Senior ConsultantsWe are looking for smart, self-driven, high-energy people with top-notch communication skills, intellectual curiosity and passion for excellence. Our analysts have a blend of in-depth domain expertise, strong analytical and conceptual thinking skills and excellent soft skills.
We are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation, Risk Management and Audits

• 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
• 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
• Preferable IT background to understand larger impact of architecture / technical complexities on the program
• Experienced in leading strategic and tactical discussions with Senior stakeholders
• MBA and/or Advanced degree (MS, MPH, PharmD and/or PhD) is preferred

Additional Responsibilities :

• 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.
• Build deep industry experience with thought leadership

Technical and Professional Requirements :At IC-LS, you will:

• 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.

Preferred Skills :Domain->LifeSciences->Clinical Trials, Compliance & Safety,Technology->Life Sciences->LIMS->Starlims,Technology->Life Sciences->Regulatory Systems,Domain->LifeSciences->Pharma Regulations->Computer Systems Validation (CSV)Educational Requirements :Bachelor of Engineering,Bachelor of Pharmacy,Master of PharmacyService Line :Infosys Consulting

Infosys