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
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