CSV Engineer

QvalFocus; Pune District; Vor Ort; INR 600.000 - 800.000; Vollzeit

Zusammenfassung

QvalFocus in Pune, Maharashtra, India seeks a CSV Specialist to perform computer system validation, remediation and data integrity assessments within a GxP environment.

You will ensure compliance with 21 CFR Part 11, EU Annex 11 and ALCOA+ principles, while maintaining audit trails, access controls and electronic records. Role involves collaboration with QA and IT teams to deliver compliant documentation and support regulatory inspections.

Qualifikationen

• GxP remediation and data integrity concepts required.
• Experience with regulatory standards and CSV.
• Audit trails and electronic records management knowledge.

Aufgaben

• Perform CSV remediation and data integrity assessments.
• Ensure compliance with 21 CFR Part 11, EU Annex 11 and ALCOA+.
• Maintain audit trails, access controls and electronic records.

Kenntnisse

GxP remediation

Data integrity

Regulatory standards

Ausbildung

B.Pharma

Jobbeschreibung

Posted: 2 days ago Openings: 1 Applicants: 50+

Responsibilities

• GxP CSV remediation & Data Integrity assessments
• 21 CFR Part 11, EU Annex 11, ALCOA+
• Audit trails, access controls & electronic records

Role Category: Pharmaceutical & Biotechnology

Education

UG: B.Pharma in Any Specialization

Key Skills

Skills highlighted with ‘‘ are preferred keyskills

QvalFocus is a premier professional services firm delivering quality-driven solutions by aligning top talent with industry leaders across Life Sciences and IT, enabling career growth for employees and measurable success for our customers through exce

Opening For CSV - Computer system Validation

Global B2B engineering & design tech firms