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Job Description ::
Technical/Functional Skills
- Regulatory Compliance and Computer System Validation Consulting Capabilities
- Technical Authoring Skills with mastery over tool (MS Office Suite, Adobe)
Experience Required
Required
- 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 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
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