This Senior QA is a self-starter and results-oriented Quality Assurance and Validation professional with 19 years of biotech and pharmaceutical industry experience managing, multiple priorities and complex projects through effective interpersonal and communication skills. Experience in providing Quality oversight and Validation deliverables for FDA and EU regulated GxP IT systems. In addition, has experience with Adverse Event Management, Regulatory Submission/Publishing, EDMS, ERP, MES, LIMS, LMS and its associated Hardware Infrastructure.
- Microsoft Dynamics Great Plains and LiveLink: Co-Lead for defining validation strategy and authoring deliverables (Validation Plan, IQ, OQ, PQ, UAT, Trace Matrices, Risk Assessments and Validation Summary Report) for presentation to Business and QA for approval.
- Authored validation templates and SOPs such as Configuration Management and Source Code Review.
- Performed analysis of current business processes to translate development documents into user requirements, and functional design specifications.
- Applied expertise in GxP and FDA, EU regulations and ICH guidance documents to the process of QA oversight and regulatory compliance of GxP in-house and Cloud based computerized systems.
- Defined the QA strategy for the oversight of regulated GxP computer systems to ensure that these systems are implemented and maintained in conformance with relevant company policies and procedures, as well as regulatory expectations.
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