Csv Validation Engineer

6 days ago

Jaipur Pune, India Circulants Full time ₹ 7,00,000 - ₹ 12,00,000 per year

Key Role

  1. Develop, write, and maintain compliance and quality-related documents, including:

  2. Standard Operating Procedures (SOPs)

  3. Work Instructions (WIs)

  4. Validation Protocols (IQ/OQ/PQ)

  5. Risk Assessments

  6. Quality Manuals

  7. Audit Response Documentation

  8. Collaborate with QA, Regulatory, IT, and Project teams to gather inputs and ensure document accuracy and clarity.

  9. Translate complex technical and regulatory content into structured, user-friendly documentation.

  10. Ensure all content complies with applicable FDA, EMA, and ICH guidelines and client-specific quality frameworks.

  11. Assist in preparing documentation for client audits, internal assessments, and regulatory inspections.

  12. Maintain version control, change history, and document archiving using tools like SharePoint, Veeva Vault, or Documentum.

Contribute to the development of training materials and knowledge-sharing resources Role & responsibilities

Technology Hands on Exp : AWS, Azure, GCP, SAS, BI, Databricks, sFTP, SaaS, PaaS, IaaS

Domain: GDP, GxP, GAMP, CRO, 21 CFR Part 11, FDA, NDA, ALCOA+, QMS, SOP

Preferred candidate profile

We are striclty looking for System Validation side not For Medical Devices, Equipments or Instruments validation side

Relevant Work Experience/Job Requirements:

  1. Hands-on experience in Computer System Validation (CSV) including preparation of VMP, URS, FS, RTM, IQ/OQ/PQ, and validation reports.

  2. Strong understanding of GxP, 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines with exposure to regulatory audits.

  3. Experience with quality and compliance documentation including SOPs, change controls, deviations, and CAPA in a pharma environment.

  4. Practical knowledge of EDMS/QMS systems, LIMS, MES, and electronic signature platforms.

  5. Proven ability to collaborate with QA, IT, Manufacturing, and Regulatory teams for compliant system implementation and maintenance.

Must have Skill sets required:

  1. Computer System Validation (CSV) Expertise Hands-on in preparing and executing VMP, URS, FS, RTM, IQ/OQ/PQ, and validation reports.

  2. Regulatory & Compliance Knowledge Strong understanding of GxP, 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity principles.

  3. Quality Documentation & Audit Readiness Skilled in SOPs, change control, CAPA, deviations, and maintaining audit-ready records.

  4. Technical & System Knowledge Familiar with EDMS, QMS, LIMS, MES, and electronic signature platforms in regulated environments.

  5. Cross-functional Collaboration & Communication Ability to work closely with QA, IT, Manufacturing, and Regulatory Affairs teams.

Technology Hands on Exp : AWS, Azure, GCP, SAS, BI, Databricks, sFTP, SaaS, PaaS, IaaS

Domain: GDP, GxP, GAMP, CRO, 21 CFR Part 11, FDA, NDA, ALCOA+, QMS, SOP

Other Skills:

  1. Risk Assessment & Impact Analysis Ability to perform risk-based validation and assess system changes for regulatory impact.

  2. Data Integrity & Audit Trail Review – Ensuring compliance with ALCOA+ principles and monitoring system audit trails.

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