GxP Validation
2 days ago
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 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.
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.
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 .
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 .
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, GxP environments).
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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