Job Title SQA Engineer Duties Implements quality procedures and provides Quality support and guidance to the Drug Safety Informatics team for the development and operation of computerized systems Ensures that the applicable regulations, guidelines and internal procedures related to validation of computer systems are followed and applied during all stages of the defined software development life cycle (SDLC) and project phase activities Analyzes the validation impact of changes and helps in formulating the validation strategy for changes to existing or new computer systemsReviews and provides input to SDLC documentation including testing and other validation deliverables Supports risk assessment and control activities Supports system lifecycle processes such as change control and document management Provides training related to computerized systems quality and compliance Assists in resolving and documenting technical and project-related issues. Skills :Job Qualifications Six years of commercial validation experience in a GxP environment in the biotech or pharmaceutical; Formal training and proficiency in software development methodologies and computer systems validation in regulated industries (biotech/pharma). Expertise in interpretation of the applicable regulations that impact computer systems (e.g., 21 CFR Parts 11, 50, 58, 312) used in GxP environment and related FDA guidelines, regulations, as well as ICH GCP guidelinesApplication of industry guidance and best practices regarding the validation and documentation of computer systems (e.g., GAMP). Must be able to manage multiple tasks, be able to work independently, and have strong oral and written communication skills. Customer focus and being a team player are a must Experience in Drug Safety systems validation and working in global teams is a plus. Keywords Education BA degree in Computer Science or a related discipline # of Positions 1
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