Principal, Quality Assurance, GMP
About the position Responsibilities • Identify gaps, formulate solutions, and drive closure to achieve and maintain compliance with cGMP standards within the WSS laboratories. • Partner with key stakeholders to ensure that identified improvements are aligned with strategic global quality and lab requirements. • Provide expertise and guidance for regulatory and industry expectations in terms of data integrity requirements: computer system validation, audit trail, electronic signature, data storage and retention. • Perform recurring laboratory audits of quality test methods and results per established West procedures to confirm they are globally harmonized with respect to data recording and documentation. • Identify and implement meaningful metrics and KPI's to measure and improve WSS laboratory compliance. • Provide guidance to QA and WSS Lab during regulatory and client audits on issues related to Data Integrity and Computer System Validation (CSV). • Actively engage with the laboratory team to drive the completion of investigations and manage backlog when necessary; regularly analyze data trends to implement improvements and ensure customer expectations are met through effective reporting and communication. • Assist the QA Manager by ensuring WSS team members are trained in GMP-relevant topics and ensuring compliance with quality system documents, cGMPs, ISO standards, and FDA regulations. Requirements • Bachelor's Degree and/or Masters in Science Technology or Engineering. • 8 years of quality-related experience with preferred experience in pharmaceutical and/or medical device industry. • Expertise of cGMP requirements, ISO standards and FDA regulations. Nice-to-haves • Create multifaceted Laboratory procedures on GMP related topics such as data documentation, processes, documentation templates, etc., in alignment with global laboratory strategies. • Perform Expert-Level GMP review and approval of global laboratory documentation, i.e. check for compliance of Lab Records to cGMP requirements related to the activities of the global SME group. • Working knowledge of various analytical instruments software and integration with LabVantage LIMS, Waters Nugenesis SDMS and Waters Empower desired. • Familiarity with MasterControl, SAP and working knowledge of statistical data analysis. • Thorough understanding of validation activities and risk management principles and techniques. • Fluent in English. • Excellent written and verbal communication skills. • Strong problem-solving and critical thinking skills. • Support and contribute to Lean Sigma programs and activities towards delivery of the set bolthires. Apply tot his job Apply tot his job