Thu Apr 21, 2016 12:18 pm (PDT) . Posted by:
Our client is seeking a Quality Validation Manager who will be responsible for supporting activities associated with cGxP compliance of computer system validation. The role is responsible for ensuring the timely review and approval of all validation records and documentation i.e. computer system validation lifecycle documentation and validation, quality records (e.g., SOPs, Change Controls, CAPAs, Deviations, etc.) are compliant with in-house specifications, standards and procedures and industry best practices.
This is a 1 year w-2 contract in New Haven, CT.
Skills and Requirements
� BS/BA degree in Engineering, Chemistry, Biology and/or related field; advanced degree preferred.
� Minimum of 8-10 years Computer System Validation related experience in biopharmaceutical / pharmaceutical or related industry with minimum of 3-5 years of direct QA oversight experience preferred.
� Solid experience establishing through validation and maintaining the validated state of enterprise computerized systems, including the following systems: Watson LIMS, REES, RAVE and Argus.
� Solid knowledge of GAMP5, System Development Lifecycle (SDLC) and IT infrastructure, including SaaS, data integrity and data management best practices.
� Prefer 3-5 years change management experience.
� Excellent critical thinking and problem solving skills.
� Excellent communication style that assures clear and concise communications
� Experience in working with geographically and culturally diverse teams
Interested candidate should email firstname.lastname@example.org their resume, current rate, target rate and how they match the requirements.
Please visit our website at www.itechcp.com for more information about our company and a list of our hot jobs.
ITech Consulting Partners
30 Church Hill Road
Newtown, CT 06470
203-270-0051 Ext: 301
Providing IT professionals on a contract or fulltime basis.
Please visit our website for more information about our company and a list of our hot jobs: www.itechcp.com
linkedin profile: www.linkedin.com/in/johnbarryitech