Sr Analyst-Quality

The Senior Analyst – Digital Quality Assurance acts as an independent quality reviewer and approver for Computer Software Validation (CSV) documentation. This role ensures that all GxP computer systems comply with West's procedures, global quality standards, and applicable regulatory requirements. As a key member of the Digital Quality Assurance (DQA) team, the Senior Analyst partners closely with cross-functional stakeholders, including the Project Team, Digital & Technology (D&T) teams (especially the Validation and Infrastructure groups), and Site/Business representatives(as applicable). Essential Duties and Responsibilities Ensure adherence to West’s global CSV procedures and support the qualification and validation of new or upgraded GxP software applications and process improvements. Collaborate with project and technical teams to ensure regulatory and quality requirements are clearly defined, documented, and implemented for GxP applications. Review test protocols, test execution records, and deviations, ensuring complete and compliant evidence of validation testing. Review and approve change control documentation related to GxP computerized systems to ensure continued compliance and system integrity. Review and approve periodic reviews of GxP computer systems to verify compliance with current procedures, standards, and regulations. Deliver training and guidance to D&T teams, including validation engineers and system owners, on CSV processes, data integrity principles, and the application of quality system procedures. Support the Digital QA Lead during internal and external audits, inspections, and assessments related to QMS and CSV documentation. Participate in the preparation, review, and approval of Quality Assurance documentation related to digital systems, including quality plans, risk management records, and audit responses. Contribute to the creation, review, and periodic update of CSV procedures and work instructions, aligning them with current regulatory expectations and industry best practices. Participate in global quality initiatives and events, collaborating across teams to strengthen quality culture and promote continuous improvement within digital systems compliance. Additional Responsibilities Ensure adherence to corporate Quality System requirements Education Bachelor’s degree in Life Sciences, Engineering, Computer Science, or a related discipline. Work Experience Minimum 5-8 years of experience in regulated Quality Assurance / Quality Control required and Experience with qualifications, Quality Risk Management, quality systems such as ISO 13485, 21 CFR 820, ISO 14971, Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Risk Management, DHF Activities, MasterControl, SAP, Share Point, Teamcenter preferred Preferred Knowledge, Skills and Abilities Ability to work independently, multi-task and thrive in fast-paced environment Must have effective problem solving and interpersonal skills Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point Able to comply with the company’s safety policy at all times Comprehensive knowledge of the end-to-end Computer System Validation (CSV) process, including planning, execution, documentation, and maintenance. Familiarity with the Computer Software Assurance (CSA) approach and its application in risk-based validation strategies. Understanding of Agile and Waterfall methodologies used in software development and validation lifecycle. Strong interpersonal, communication, and teamwork abilities, with a proven capacity to work collaboratively under guidance in a cross-functional environment. License and Certifications Travel Requirements 5%: Up to 13 business days per year Physical Requirements Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Additional Requirements Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events. Must maintain the ability to work well with others in a variety of situations Must be able to multi-task, work under time constraints, problem solve, and prioritize Ability to make independent and sound judgments Observe and interpret situations, analyze and solve problems Maintain high attention to detail, accuracy, and overall quality of work. Effectively communicate and interface with various levels internally and with customers. Able to be aware of all relevant SOPs as per Company policy and Quality Manual What We Offer Shift West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to [email protected] . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening.