Senior Validation Specialist

VersaTech Consulting Inc a division of Mascon Global a leader in the Information Technology Services Industry. With a reputation for quality service, VersaTech brings a long and successful track record of meeting the business needs of a wide range of Fortune 500 and middle market companies. These companies have come to expect ONLY THE BEST candidates from VersaTech and that’s exactly what we deliver. As a result VersaTech has established itself as the Primary Source of Contract and Permanent opportunities with our direct end clients in the Pharmaceutical/Biotech, Luxury Automotive, Manufacturing, Retail, Telecommunications and Financial/Banking industries.

We offer employment to W2 hourly, Independent Contractors and full time salaried employees. Our employees can take advantage of our competitive benefits package that includes a health plan, 401k, provisions for vacation and holiday pay, and technical and professional training. Compensation is commensurate with experience. VersaTech is an equal opportunity employer.

 

Minimum Education level Bachelor Degree Required

Job Description:-
Senior Validation Analyst with 8-10 years of IT experience. Apply FDA, MHRA, and other applicable global regulations to the development of computer systems supporting regulated business processes
• Follow SOPs and industry best practices
• Conduct training on good documentation and good testing practices
• Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system
• Review validation deliverables for projects which are contracted to third party suppliers
• Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues
• Assist in planning, implementing, and documenting user acceptance testing. Ensures problems are clearly stated
• Summarizes results of investigation activity from multiple teams, identifies gaps in problem analysis and scope.
• Summarizes conclusions from multiple teams and identifies gaps.
• Summaries corrective actions from multiple teams and assesses corrections to ensure problems are addressed
• Assess root causes identified by teams and identifies gaps.
• Based on root cause analysis, recommends appropriate preventative actions to ensure identified problem will not re-occur.
• Writes final CAPA report to include problem statement, investigation, conclusions, corrective actions and preventative actions--MUST HAVE
• Presents results to management team and updates report to meet management team expectations.

To apply, Please forward your word doc resume with Availability, Contact Details and Salary Requirements to Priti Arora (Technical Recruiter) at priti.arora@vtcons.com or priti.arora@mgl.com or call directly on 732-726-4212 .