Business Consulting : Computer System Validation

India's marquee global technology company. They are an international flag-bearer of technical and managerial excellence. With offices around the globe, the company has a comprehensive presence across multiple segments of the IT product and service industries. They are a respected career company and a long-term wealth creator.

Location: Hyderabad/Bangalore/Chennai/Pune/Mumbai/Delhi/NCR/Kolkata

Purpose of the role & key responsibilities:

• Lead project compliance work streams, responsible for end to end quality and compliance aspect of the project, validation deliverables, client buy-in and reporting leading to successful project delivery and client delight
• Engage with key stakeholders for execution of day-to-day interactions with client teams
•  Participate in practice development activities
• Strong business consulting and excellent soft skills Demonstrates proven success in roles and thorough abilities in one or more of the areas.
• Understanding of key Pharmaceutical compliance regulations like Computerized System Validation, 21 CFR part 11, GxP, GAMP 5 and SOX IT
• 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 various Validation tools and templates used throughout the Pharmaceutical industry
• Working knowledge of Risk Management, periodic or control maturity assessment and Audits
• Must have global client exposure and have worked in Global delivery model

Your Profile

5-15 years of computer System validation experience in Life Sciences industry working for a consulting services organization and/or industry experience. Bachelors /Master degree, preferably in pharmaceutical sciences or related field.