Validation Lead

Required

• Minimum of 10 years’ experience as a Computer System Validation Consultant in a regulated environment (preferably Pharma) and must have played a lead role (able to work independently with minimal guidance).
• Worked in a Pharmaceutical company as QA / QC within the Sales and Marketing and / or Medical / Regulatory business.
• Good understanding of industry regulations (FDA and other regulatory agencies world-wide)
• Excellent communication skills with strong command over written and spoken English.
• Technical Writing experience and expertise with relevant tools (MS Office Suite, Adobe documentation Suite) Desired
• Risk Management, Supplier evaluation and assessment and auditing experience is highly desirable.
• Experience of working in virtual teams across different cultures and geographies
• Experience of working with cloud-based technologies is desired
• Play a client facing Compliance Lead role in projects, programs, and support work.
• Provide consulting and guidance on quality and compliance needs to IT project teams and enable them to achieve compliance using a risk-based right-sizing approach.
• Take ownership of assigned project / program / support responsibilities and deliver to committed timelines.
• Meet quality expectations as per defined contractual obligations to the client.
• Monitor, guide and drive off-site teams to achieve defined milestones and key objectives.
• Always ensure external and internal process compliance of the team
• Resource should be quick learner and self-driven; capable of working with client partners to meet strategic Objectives.
• Resource must be able to identify, mentor and hone talent to build leaders from within a team.