- • Utilizing the companies requirements and guidelines pertaining to the Validation Life Cycle and with adherence to all applicable Quality, FDA regulations, and Safety regulations, write and execute Installation Qualifications (IQs), Operational Qualifications (OQs), Performance Qualifications (PQs), Process Validations (PVs)/Process Characterizations (PCs), Cleaning Validations/Verifications, assist in spreadsheet validation protocols, Computer Validation (using GSK established methodologies i.e. iQMS), Continued Process Validation (CPV), coordinate validation executions with Engineering, Manufacturing, Packaging, and Quality and produce the subsequent Validation Reports of the executed protocols and perform Periodic Reviews of validated systems.
• Assist System Owners (Operations, Quality) and Engineering to create User Requirement Specifications (URS) and Functional Specifications (FS), Design Specifications (DS), and other necessary design documentation, respectively, for GSK-St. Louis Systems;
• Design and champion corrective and preventative action plans (CAPAs) and change controls (CCs) in accordance with the GSK quality management system.
• Evaluate new equipment i. e. Factory Acceptance Testing (FAT) to ensure the equipment meets User Requirements;
• Perform statistical analysis on the validation data generated and organize the data in tabular or graphical form;
• Improve compliance by writing and/or revising Validation and related SOPs;
• Participate in Operation Excellence (OE) initiatives, cross-functional teams, and special projects as required;
• Complete internal and external Audit findings as assigned.
• Ensure quality and compliance in accordance with established procedures and standards of the Quality System.
• Comply with and support the companies Environmental, Health and Safety policies and procedures.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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