GxP Validation & Compliance Specialist

Job 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 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

Good to Have (Optional)

Why Join Us?