Role: Business Analyst 2 - Validation BA
Work Location: Atlanta, GA
A business analyst with 5-6 years of System Validation (CSV) / GxP experience . Looking for the under mentioned skills and experience:
o Ability to quickly learn and adapt Client's validation and regulatory framework.
o Execution of projects through Change Control (enhancement and incremental projects) and entire Validation Life Cycle (high-risk, larger projects).
o Ability to conduct high-level and detailed assessment to identify the validation scope and validation protocol applicable to the project release
o Document management experience with SOPs/IOPs and Project Management documents such as URS, FRS, Design Specifications to ensure the URS, FRS, Design specifications meet relevant validation protocols as set forth per client framework
o Knowledgeable and experienced with authoring and execution of validation artifacts; Validation plans, IQ, OQ and PQ and Validation Reports to ensure process and product validation, including deviation management and control.
o Integration of testing activities with Validation activities such as requirements matrix and trace matrix
o Has been involved with providing Validation training
o Develop and maintain CAPA (good to have)
o Good understanding of the LifeSciences industry regulatory framework (GLP, GCP,GMP and GAMP) and other regulatory frameworks (SOX, ISO)
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