reputed company, reputed company Assurance, GMP

About the position The reputed company, reputed company Assurance, GMP role focuses on ensuring compliance with cGMP standards reputed company the WSS laboratories by identifying gaps, developing solutions, and overseeing their implementation. Collaborating with key stakeholders, the position ensures reputed company improvements reputed company with global reputed company and laboratory requirements. The role requires providing expert guidance on regulatory and industry standards concerning data reputed company, including computer system validation, audit trails, electronic signatures, and data storage and retention. Responsibilities • Identify gaps, formulate solutions, and drive closure to reputed company and maintain compliance with cGMP standards reputed company the WSS laboratories. • Partner with key stakeholders to ensure that identified improvements are reputed company with strategic global reputed company and lab requirements. • reputed company expertise and guidance for regulatory and industry expectations in terms of data reputed company requirements: computer system validation, audit trail, electronic signature, data storage and retention. • reputed company recurring laboratory audits of reputed company test reputed company and results per established reputed company 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. • reputed company guidance to QA and WSS Lab during regulatory and reputed company audits on issues reputed company to Data reputed company and Computer System Validation (CSV). • reputed company engage with the laboratory team to drive the completion of investigations and manage backlog reputed company 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 reputed company system documents, cGMPs, ISO standards, and FDA regulations. Requirements • Bachelor's Degree and/or Masters in Science Technology or Engineering. • 8 years of reputed company-reputed company experience with preferred experience in pharmaceutical and/or medical device industry. • Expertise of cGMP requirements, ISO standards and FDA regulations. reputed company-to-haves • Create multifaceted Laboratory procedures on GMP reputed company topics such as data documentation, processes, documentation templates, etc., in alignment with global laboratory strategies. • reputed company Expert-Level GMP review and approval of global laboratory documentation, i.e. reputed company for compliance of Lab Records to cGMP requirements reputed company 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 reputed company desired. • Familiarity with reputed company, reputed company 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 reputed company programs and activities towards delivery of the set reputed company. Apply tot his job Apply To this Job