Validation Consultant
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Validation Consultant
Ref No.: 18-23222
Location: Bridgewater, New Jersey
Position Type:Right to Hire
Start Date: 04/05/2018
 
Job Title   Validation Consultant
Relevant Experience (Yrs)  7+ years
Technical/Functional Skills ·        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)
Experience Required ·        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
Education
Graduate in any discipline (Computer Sciences or related is preferred).
Work Location Bridgewater, NJ, USA