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Mumbai City, Maharashtra, India · On-site
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Mumbai City, Maharashtra, India · On-site
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Mumbai City, Maharashtra, India · On-site
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Mumbai City, Maharashtra, India · On-site
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Mumbai City, Maharashtra, India · On-site
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Mumbai City, Maharashtra, India · Hybrid
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Mumbai City, Maharashtra, India · On-site
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Mumbai City, Maharashtra, India · On-site
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Mumbai City, Maharashtra, India · On-site
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The Senior Manager will lead Computer System Validation (CSV) initiatives and ensure IT compliance across various client projects. They will oversee the end-to-end validation lifecycle, including the creation of GxP documentation and the management of quality systems.
Candidates must have over 10 years of experience in CSV, software testing, and IT compliance, with a strong understanding of GxP and FDA regulations. A degree in Pharmacy or Engineering is required, along with proficiency in validation methodologies and defect tracking.
Job Description & Summary:A Career with in............................
Responsibilities
Having 4-8 years of work experience in Computer System Validation (CSV), Software Testing and IT Compliance.
Exposure in Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC).
Knowledge of SDLC methodology like Waterfall and Agile model and V model of CSV.
Experience in manual testing like Positive & Negative Testing, Regression Testing, Smoke, Sanity Testing and defect tracking and reporting. (Preferred exposure to CSV tools such as Valgenesis)
Knowledge of GAMP5 Guideline, GxP, US FDA 21 CFR Part 11, EU Annex 11 and ALCOA+ principles.
Knowledge of Change Control, Deviation Management, CAPA and Periodic Review.
Experience in authoring Computer System Validation deliverables like GxP Assessment, Validation Plan (VP), User Requirement Specifications(URS), Functional Requirement Specifications(FRS), Functional Risk Assessment (FRA) using FMEA, Design Specifications (DS), IQ/OQ/PQ protocols, Validation Summary Report (VSR)
Mandatory Skill sets
CSV
Preferred Skill sets
LIMS/QMS
Years of Experience Required
10+ years
Education Qualification
B.Pharm/M.Pharm/B.Tech
Education (if blank, degree and/or field of study not specified)
Degrees/Field of Study required:Degrees/Field of Study preferred: Bachelor of EngineeringCertifications (if blank, certifications not specified)
Desired Languages (If blank, desired languages not specified)
At PwC, we help clients drive their companies to the leading edge. We’re a tech-forward, people-empowered network with more than 370,000 people in 149 countries. Across audit and assurance, tax and legal, deals and consulting we help build, accelerate and sustain momentum. Find out more at www.pwc.com. PwC: Audit and assurance, consulting and tax services PwC refers to the PwC network and/or one or more of its member firms, each of which is a separate legal entity. Content on this page has been prepared for general information only and is not intended to be relied upon as accounting, tax or professional advice. Please reach out to your advisors for specific advice.
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There are currently 2,474 open consulting positions in Mumbai City, India listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include Accenture, PwC, Genpact, Morgan Stanley, Deutsche Bank, among others. Browse the listings above to see every active employer.
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