22 Aug
|
Infosys
|
Bengaluru
Educational Requirements
- Bachelor of Engineering
- Bachelor of Pharmacy
- Bachelor of Science
- Master of Business Administration
- Master of Pharmacy
- Master of Science
Service Line
Infosys Consulting
Responsibilities
- Be responsible for the delivery of business results to global health and life sciences clients.
- Serve as a team member, track lead or engagement lead on business consulting engagements for clients.
- Execute consulting engagements in a global delivery model, working with consultants across regions.
- Analyze problems, and structure complex business analyses.
- Work with cross functional client teams to perform gap analysis and identify improvement options.
- Effectively collaborate with the internal and external stakeholders.
- Participate in a variety of firm building events.
Additional Responsibilities
- Knowledge of validation tools and templates used in the pharmaceutical industry.
- Proven ability in supporting multiple projects, responding quickly to changing situations in complex environments.
- Preferable IT background to understand complexities on the program.
- Experience in Agile and waterfall methodology.
- Knowledge and hands on experience in conducting periodic or control maturity assessment and Audits.
- Knowledge in SaaS/Cloud.
Technical and Qualified Requirements
- 4-14 years of professional experience in the Life Sciences industry working for a consulting services organization and/or industry.
- Good understanding of key pharmaceutical compliance regulations like 21 CFR Part 11, GxP and GAMP 5.
- Experience creating, reviewing and approving / acknowledging validation deliverables.
- Knowledge of risk management process and quality management requirements which assures that IT Projects meet Quality and Regulatory requirements.
- Experience in validation of Enterprise applications such as SAP / S4 HANA projects, Trackwise, QMS, DMS and etc.
- Functional knowledge in any of the domain applications such as Clinical applications like EDC, CTMS etc., Regulatory applications like CDR, or any other applications/system used in Pharma industry.
- Thorough knowledge in compliance and validation concepts. (Change, Deviation, Supplier management).
Preferred Skills
- Domain: Healthcare: Regulatory Compliance & Standards
- Domain: LifeSciences: LifeSciences - ALL
- Technology: Life Sciences: Regulatory Systems
- Technology: Risk Management: Risk Management System
- Domain: LifeSciences: Pharma Regulations
📌 Life Sciences Management Consultant - (GRC) (Bengaluru)
🏢 Infosys
📍 Bengaluru