GxP Validation

7 days ago

Bengaluru, India Prana Tree Full time

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

  • 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, GxP 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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