Position: QA with Validation & GMP exp Location: Groton, CT
Duration: 6+ months Rate: $37/Hr Best Job Description: QA Consultant with validation and GMP experience The Validation QA Consultant, in alignment with the Validation Team, will work to apply global Quality Systems policies and procedures to validation activities for the GDS program. Serves the QM organization as a primary point of contact for quality support requests from the Business & Informatics to ensure that computerized systems are developed & managed in accordance with corporate, regulatory & Informatics standards. Work closely with Informatics project managers, teams and associated Business QA groups to ensure SLC deliverables are consistent & satisfy the above requirements and meet business needs. Tasks include writing, revising, and verifying QM deliverables (Quality Planning & Compliance Reporting), reviewing and approval of SLC deliverables (Project planning, requirements and verification). Tasks also include contributing to implementation and post implementation planning and monitoring to support effective performance and change management practices. Excellent communication skills are required, capable of performing effectively within a project team, or with minimal supervision. Organizational Relationships: ** Reports to the Global Quality Operations GDS Computer Validation QA Lead. ** Liaise with colleagues within GDS program team, WW Pharmaceutical Sciences and Informatics as appropriate Primary Duties: ** Provides QA GMP(Good Manufacturing Practices) support by reviewing computerized system validation test cases and other quality deliverables as needed. , ** Collaborate with business in the creation of validation test cases and documentation. ** Participate on the validation project teams A minimum of 5 years of GMP validation experience within the Pharmaceutical Industry. Experience in applying cGMP 21CFR 210/211, GAMP and 21CFR Part 11 regulations as required for the validation and qualification of computer systems used for the manufacture and testing of clinical supplies or commercial pharmaceuticals. A thorough technical knowledge informatics systems validation is necessary. --~--~---------~--~----~------------~-------~--~----~ You received this message because you are subscribed to the Google Groups "IT provider" group. To post to this group, send email to [email protected] To unsubscribe from this group, send email to [EMAIL PROTECTED] For more options, visit this group at http://groups.google.co.in/group/IT-provider?hl=en -~----------~----~----~----~------~----~------~--~---
