Sr Computer System Validation Analyst

Proven Tech; Hyderabad; Vor Ort; INR 900.000 - 2.500.000; Vollzeit

Zusammenfassung

Proven Tech is seeking an experienced CSV Consultant to join our pharma IT compliance team. The role requires strong knowledge of GxP regulations and validation lifecycle activities across manufacturing, QA, and laboratory environments.

You will execute CSV activities, perform gap assessments, validate systems (PLC/SCADA/HMI exposure where applicable), review documentation, and support audits with inspection-ready deliverables, ensuring GDP and ALCOA+ data integrity.

Qualifikationen

• Experience validating computerized systems in pharma manufacturing or QA environments.
• Strong knowledge of GxP, regulatory requirements, and validation lifecycle.
• Experience with IQ/OQ/PQ, RTM, and validation documentation.
• Familiarity with GDP and data integrity principles (ALCOA+).

Aufgaben

• Execute CSV activities for GxP systems per regulatory requirements.
• Conduct gap assessments and identify compliance gaps.
• Perform retrospective validation and compliance assessments.
• Prepare and review validation plans, URS, FRS, IQ/OQ/PQ, and VSR.
• Ensure adherence to GDP and data integrity standards.
• Support audits with inspection-ready documentation.
• Collaborate with QA, IT, engineering, manufacturing, and QC teams.
• Manage change control, deviations, CAPA, and remediation.

Kenntnisse

CSV

Pharma/Life Sciences

Gap Assessment

Retrospective Validation

GxP Compliance

GAMP 5

21 CFR Part 11

EU Annex 11

ALCOA+

IQ/OQ/PQ

Risk Assessment

Validation Documentation

RTM

PLC/SCADA/HMI exposure

Jobbeschreibung

Job Description – Computer System Validation (CSV) Consultant

Position: CSV Consultant Experience: 2–8 Years Locations: Bangalore & Indore Joining: Immediate Joiners Preferred Industry: Pharmaceutical / Life Sciences

Job Summary

We are looking for experienced Computer System Validation (CSV) Consultants with strong knowledge of pharmaceutical IT compliance, GxP regulations, validation lifecycle activities, and Gap Assessment / Gap Analysis. The ideal candidate should have experience validating computerized systems used in pharmaceutical manufacturing, quality control, laboratory, or enterprise environments.

Roles and Responsibilities

1. Execute Computer System Validation (CSV) activities for GxP computerized systems in accordance with regulatory requirements.
2. Conduct Gap Assessments and Gap Analysis to identify compliance gaps against applicable regulatory standards and internal procedures.
3. Perform retrospective validation and compliance assessments for existing computerized systems.
4. Prepare and review validation documentation, including Validation Plans, URS, FRS, Risk Assessments, RTM, IQ/OQ/PQ protocols, and Validation Summary Reports.
5. Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+ data integrity principles.
6. Perform system impact assessments, risk assessments, and data integrity assessments.
7. Validate laboratory and manufacturing systems, including relevant applications involving PLC, SCADA, and HMI, where applicable.
8. Review test scripts, test execution evidence, deviations, and validation deliverables.
9. Support change control, deviation management, CAPA, and remediation of identified compliance gaps.
10. Collaborate with QA, IT, engineering, manufacturing, and QC teams to ensure regulatory compliance.
11. Support internal and external audits by maintaining complete and inspection-ready validation documentation.
12. Ensure adherence to Good Documentation Practices (GDP) and applicable pharmaceutical quality standards.

Required Skills

• Computer System Validation (CSV)
• Pharmaceutical / Life Sciences experience
• Gap Assessment and Gap Analysis
• Retrospective Validation
• GxP Compliance (GMP/GLP/GCP)
• GAMP 5
• 21 CFR Part 11 and EU Annex 11
• Data Integrity and ALCOA+
• IQ/OQ/PQ and Risk Assessment
• Validation Documentation and RTM
• PLC, SCADA, HMI, laboratory or manufacturing systems exposure

Audit Readiness, Change Control, and CAPA