Quality Manager - Groton, CT

Quality Manager - Groton, CTPrimary Duties: o Provides QA GMP support by reviewing computerized system validation test cases and other quality deliverables as needed.  o Collaborate with business in the creation of validation test cases and documentation. o Participate on the validation project teamsTraining & Education Preferred: o BS or MS degree in Science or Engineering.  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.  Prior Experience Preferred o Prior Quality Assurance experience is a strong plus. o Computerized system validation experience requiredo Needs excellent oral and written Communication Skills, excellent cGMP documentation skills, strong organizational and technical writing skills and ability to work in a team-based dynamic environment, adapting to changing priorities.  Technical Competencies: Competency   Detail / Comments (specific skills, etc.) o Knowledge of validation requirements in a GMP environment.  o Application and Problem Solving. o Planning and Organization  o This includes knowledge of regulatory, corporate, Pharmaceutical Sciences, and local validation policies and guidances.  o Is detail oriented & pragmatic o Sets appropriate priorities o Establishes course of action & follow through o Takes initiative/is a self-starterBehavioral Competencies: Competency   o Listening and Learning o Shared Accountability (Contributing to Team Success) o Manage Change  o Cooperative team member o Quickly finds common ground and solve problems for the good of all o Effectively copes with change & ambiguity o Learns from mistakes and implements improvements based on learningsPlease send your word resume to jlane@smithhanley.com If you would like to be considered for this opportunity, please forward your resume to the email address provided below. If you meet the minimum requirements someone will be in touch with you to discuss the specific details. Education Level: Bachelor's Degree Job RefCode: 3025368 Email: Apply by Email