| Senior Quality Lead at Remote, Remote, USA |
| Email: akash.s@tekinspirations.com |
|
From: Akash Sharma, Tek inspirations akash.s@tekinspirations.com Reply to: akash.s@tekinspirations.com Title: Senior Quality LeadLocation: Boston, MA-HybridMOI: F2FMUST BE LOCAL TO MAMUST HAVE LINKEDIN - Make sure candidate should not multiple LinkedinMUST HAVE PHARMA INDUSTRY EXPERIENCEThis position will be responsible for supporting the QISM group at Vertex, specifically focused on IT Infrastructure and the Clinical Operations areas. This position will be working closely with the operational functions, DTE (IT), and other GxP QA groups to provide oversight of computerized system implementation, maintenance, and retirement used in these areas. This role will review and approve computerized system lifecycle documentation as well as provide Part 11/ Annex 11, and data integrity expertise to key stakeholders internal to Vertex.MINIMUM QUALIFICATIONS: Bachelor's degree and relevant GxP work experience Proficiency in using Microsoft Office applications 8-10 experience performing validation activities.Experience with the following: Performing Quality Assurance function related to Clinical Computerized Systems / Infrastructure Proficiency with regulations related to FDA / MHRA regulations Use of computerized quality management systems Experience with validation of Enterprise / Lab Computerized Systems. Quality metrics, dashboards, analysis and improvement programs Knowledge of GAMP and Agile validation lifecycle and methodologiesKEY RESPONSIBILITIES: Has understanding of regulations pertaining to the implementation and use of computerized systems in all GxP areas. Participates in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy to be followed using a risk-based approach based on GAMP 5. Reviews and approves system lifecycle deliverables for new and modifications to computerized systems used in the GxP areas Consults with QISM team members and relevant internal stakeholders to identify / define high risk areas with the intent on focusing on patient safety, product quality and data integrity. Identifies and escalates areas of risk or non-compliance to manager / leadership team Participates in performing Periodic Review activities of Computerized Systems Provide support to regulatory inspection preparedness activities as needed Experience performing Infrastructure Qualification activities Keywords: quality analyst information technology Massachusetts Senior Quality Lead akash.s@tekinspirations.com |
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| 02:55 AM 11-Feb-25 |