CSV Engineer

Roles & Responsibilities

• 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

• Minimum of 5 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 manufacturing area.
• 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.