Gxp validation

4 weeks ago

Bangalore, India Prana Tree Full time

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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