· Regulatory Compliance and Software Validation Consulting Capabilities · Technical documentation authoring skills with mastery over MS Office Suite · Experience using Document management tools (Documentum, Regulus), Client QC, Change Management tools (ServiceNow)
· Minimum of 5 years experience as a Computer System Validation Consultant in a regulated environment (preferably Pharma) and must have played leadership role/s. · Good understanding of Quality concepts, regulations (FDA and other regulatory agencies world-wide) · Worked in a Pharmaceutical company as QA/QC within the Sales and Marketing and/or Medical/Regulatory areas · Excellent communication skills with strong command over written and spoken English · Good Technical documentation skills · Experience of working in multi-cultural teams across multiple time zones
Additional Expectations · Risk Management, Supplier evaluation and assessment and auditing experience is highly desirable · Knowledge of Testing tools and processes · Work experience in an Onsite-offshore model is highly desirable
Roles & Responsibilities
· Play a client facing Compliance Lead role in projects, programs and support work · Experience of working in large scale solution deployment programs/projects · 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 for 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 team to achieve defined milestones and key objectives · Ensure external and internal process compliance of the team at all times
Generic Leadership Skills
· 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 a strong functional team
Graduate in any discipline (Computer Sciences or related is preferred).