Senior Computer System Validation Consultant

• The role involves leading computer system validation activities across the system lifecycle, ensuring regulatory compliance, data integrity, and quality governance in a biopharmaceutical environment, including validation planning, risk management, and audit readiness.

Requirement/Must Have:

• Bachelor s degree in Life Sciences or related discipline within the pharmaceutical/biotech industry.
• Strong experience in CSV (Computer System Validation) and Quality Compliance.
• Deep understanding of 21 CFR Part 11, GxP (211/820), GAMP 5, and EU Annex 11.
• Strong knowledge of data integrity and validated systems in regulated environments.
• Experience with quality management systems including Change Control, Deviations, CAPA, Document Control, Training, EDMS, and LMS.
• Strong technical understanding of IT systems, networked applications, and infrastructure in regulated environments.
• Proficiency in MS Excel, PowerPoint, and Word.
• Strong communication, collaboration, and stakeholder management skills.

Experience:

• Experience working in life sciences, biotech, or pharmaceutical environments.
• Experience in validation lifecycle management and compliance oversight.
• Experience supporting regulated GMP systems and audits.

Responsibilities:

• Author, review, and approve validation deliverables including validation plans, risk assessments, URS, configuration specifications, test scripts (IQ/OQ/PQ), and validation summary reports.
• Perform requalification and periodic reviews of existing computer systems.
• Oversee system development lifecycle processes ensuring compliance across build, test, deploy, and maintenance phases.
• Act as quality lead for project teams and guide validation and compliance activities.
• Review and approve system lifecycle documentation to ensure SOP and regulatory compliance.
• Support and lead internal and external audits and regulatory inspections.
• Conduct risk assessments and escalate compliance or security issues as required.
• Prepare compliance and validation status reports for management.
• Perform gap assessments for legacy systems and integration readiness.
• Advise teams on implementing security and compliance controls to ensure data integrity.
• Promote teamwork and align daily activities with organizational quality goals.

Should Have:

• Strong understanding of laboratory, manufacturing, and quality systems in GMP environments.
• Experience with cell and gene therapy or pharmaceutical data systems preferred.
• Strong knowledge of advanced quality systems and validation processes.

Skills:

• Computer System Validation (CSV).
• Regulatory compliance (21 CFR Part 11, GxP, GAMP 5, EU Annex 11).
• Risk management and audit support.
• Quality systems (CAPA, Change Control, Deviations, Document Control).
• System lifecycle and validation documentation.
• MS Office Suite (Excel, Word, PowerPoint).
• Data integrity and regulated system compliance.

Qualification And Education:

• Bachelor s degree in Life Sciences or related field required.