Gxp validation
16 hours ago
Job Description – Gx P Validation & Compliance Specialist (Contract) Position Type: Contract (6 Months) Open Positions: 01 Location: Bangalore (Preferred) Experience Required: 4–6 years Role Overview We are looking for a skilled Gx P Validation & Compliance Specialist to ensure that all digital twin workflows comply with global regulatory requirements, including 21 CFR Part 11 and EU Annex 11. The specialist will lead Computer System Validation (CSV)/Computer Software Assurance (CSA) activities, manage compliance documentation, and provide expertise in pharma quality systems. This role will play a key part in enabling compliant deployment of advanced digital solutions. Key Responsibilities Lead and execute risk-based validation (CSV/CSA) activities for digital twin workflows. Ensure compliance with 21 CFR Part 11, EU Annex 11 , and other applicable regulatory standards. Develop and manage validation plans, test scripts, traceability matrices, and reports . Define and validate audit trail design, electronic records, and electronic signature compliance . Support quality system documentation including SOPs, deviations, CAPAs, and change controls. Partner with engineering, IT, and QA teams to ensure seamless compliance integration . Provide training and guidance on regulatory compliance best practices. Support internal and external audits and regulatory inspections . Skills & Expertise Required Strong expertise in CSV/CSA methodologies and risk-based validation approaches . In-depth knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5 , and pharma regulatory frameworks. Experience in audit trail validation, ER/ES compliance, and system qualification . Hands-on experience with quality management systems (QMS) and pharma compliance practices. Strong documentation skills for validation deliverables and regulatory audits . Ability to collaborate with cross-functional teams in regulated environments. Good to Have (Optional) Experience with digital twin technologies in regulated industries. Familiarity with pharma manufacturing IT systems (MES, LIMS, QMS). Exposure to cloud-based systems validation (AWS, Azure, Gx P environments). Why Join Us? Be at the forefront of digital transformation in life sciences . Work on next-generation digital twin workflows in a regulated environment. Collaborate with cross-functional global teams on high-impact compliance projects . Gain experience in cutting-edge regulatory compliance practices .
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GxP Validation
2 days ago
Bangalore, India Prana Tree Full timeJob Description – GxP Validation & Compliance Specialist (Contract) Position Type: Contract (6 Months) Experience Required: 4–6 years Role Overview We are looking for a skilled GxP Validation & Compliance Specialist to ensure that all digital twin workflows comply with global regulatory requirements, including 21 CFR Part 11 and EU Annex 11 . The...
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GxP Validation
2 days ago
Bangalore, India Prana Tree Full timeJob Description – GxP Validation & Compliance Specialist (Contract) Position Type: Contract (6 Months) Open Positions: 01 Location: Bangalore (Preferred) Experience Required: 4–6 years Role Overview We are looking for a skilled GxP Validation & Compliance Specialist to ensure that all digital twin workflows comply with global...
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GxP Validation
21 hours ago
bangalore, India Prana Tree Full timeJob Description – GxP Validation & Compliance Specialist (Contract)Position Type: Contract (6 Months) Open Positions: 01 Location: Bangalore (Preferred) Experience Required: 4–6 yearsRole
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Validation Engineer
23 hours ago
bangalore, India Green HR Solutions Full timeHiring for USA based big MNC, pls Apply if following Job Description suits your aspirations.We are seeking a meticulous and experienced Validation Engineer to plan, execute, and document validation processes that ensure products, systems, and equipment meet industry standards, regulatory requirements, and company quality criteria. The Validation Engineer...
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Python AI Engineer – Synthetic Test Data
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bangalore, India Saxon Global Full timePython AI Engineer – Synthetic Test Data (Life Sciences / GxP)About the RoleWe are seeking a Python AI Engineer to design and implement intelligent frameworks for synthetic and automated test data generation in support of clinical trials, regulatory submissions, and GxP-compliant systems. This role will leverage AI/ML and Python automation to deliver...
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bangalore, India SpurQLabs | Next-Generation Software Testing & Test Automation Services Full timeSpurQLabs is an independent software testing and test automation company committed to helping clients build exceptional quality products at speed. We offer specialized services in test automation, performance testing, API testing, and CI/CD. With a vision to support clients in delivering secure, scalable, and reliable software, SpurQLabs emphasizes...
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Computer Validation Engineer(CSV)
1 week ago
Bangalore, India ACL Digital Full timeWe are seeking a highly skilled and detail-oriented CSV Technical Writer to join our team. This role demands strong documentation capabilities, effective communication, and deep exposure to the pharmaceutical industry and CSV practices. The ideal candidate will be proficient in stakeholder management, user story writing, and technical documentation...
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Computer Validation Engineer(CSV)
7 days ago
bangalore, India ACL Digital Full timeWe are seeking a highly skilled and detail-oriented CSV Technical Writer to join our team. This role demands strong documentation capabilities, effective communication, and deep exposure to the pharmaceutical industry and CSV practices. The ideal candidate will be proficient in stakeholder management, user story writing, and technical documentation including...
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Bangalore, Karnataka, India AstraZeneca Full timeJob Title Regulatory Information Management Systems Business Quality ManagerGlobal Career Level EIntroduction to roleThe RIMS Business Quality Manager is a pivotal leadership position within the Regulatory Technology Operational Excellence RTE unit at AstraZeneca This role is crucial for system ownership and business tool management ensuring that the...
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CSV Engineer
1 week ago
Bangalore, India VRR Life Sciences Full timeJob Title: CSV Executive Location: Bangalore Experience: 2-4 years Industry: Pharmaceutical / Biotechnology / Lifesciences Key Responsibilities: Perform validation activities for GxP computerized systems (planning, risk assessment, URS, IQ, OQ, PQ, summary reports) Prepare and review validation documentation in line with 21 CFR Part 11, EU...
