{"id":4096934,"url":"https://alion.io/job/west-pharmaceutical-services-analyst-digital-quality","title":"Analyst - Digital Quality","company":{"id":1923607,"name":"West Pharmaceutical Services","domain":"westpharma.com","url":"https://alion.io/company/westpharma","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":{"grade":"A","score":96,"open_postings":6,"ghost_share":0,"stale_share":0.167,"repost_share":0,"time_to_fill_p50_days":28,"computed_at":"2026-11-11T05:49:22Z"}},"role":"Analytics","role_family":"Analytics","seniority":"middle","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bengaluru, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"Agile","optional":false},{"name":"CAPA","optional":false},{"name":"Waterfall","optional":false}],"status":"live","first_seen_at":"2026-11-05T02:01:00Z","employer_posted_date":"2026-11-05","last_verified_at":"2026-11-12T03:46:03Z","board_verified":true,"closed_at":null,"days_open":7,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":7},"description":"At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?\nThere’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.\nWe believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.\nJob Summary\nThis role acts as Independent Quality reviewer and approver of Computer Software Validation documentation. As a member of the Digital Quality Assurance team, this role works closely with the Project team and the Validation team to ensure West procedural and regulatory requirements are met throughout the Computer System lifecycle of GxP Computer systems.\nEssential Duties and Responsibilities\nOversee GxP projects assigned and ensure all the computer system Validation activities are in line with West QMS and regulatory requirements.\nReview and approve Computer System Validation lifecycle documents.\nProvide inputs during GxP assessment and Risk assessment from QA perspective.\nParticipation in projects meeting and provide guidance to project team and Validation team towards CSV activities.\nFollows West procedures on Computer System Validation, supports the validation of GxP software and process improvements to software.\nWorks closely with Project team to document regulatory requirements for GxP applications.\nReviews Test Protocols/evidence, executions and execution deviations as applicable.\nReview and approve Computer software change control documentation.\nProvide training to Digital & Transformation team on CSV process.\nAssist the Digital QA lead during Internal/External audits on the QMS documentation.\nInvolve, preparation, review and approval in documentation related to Digital quality.\nAssist in CSV procedure/work instruction creation, review and approval.\nParticipation in Global quality events.\nEducation\nEducation: Batchelor or master’s degree in science related field, or Information Technology \nWork Experience\nExperience: 3-6 years \nPreferred Knowledge, Skills and Abilities\nRegulatory requirements for ERES like FDA 21 CFR Part 11, Eu Annexure 11 etc.,\nEnd to End Computer System Validation process.\nRisk Management \nExposure to Computer Software Assurance approach\nAgile and Waterfall Methodology\nAbility to work in a team environment and under guidance. \nAudit process\nIncident, Deviation and CAPA process knowledge\nExposure to AI based Computer Systems.\nPeriodic review\nTravel Requirements\n10%: Up to 26 business days per year\nPhysical Requirements\nSedentary-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.\nShift\nPrefer 12pm - 9pm India time. Willingness to work outside of these hours as needed.\nWest 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 . 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