Shweta Nigam

Associate Consultant

United Kingdom24 yrs 3 mos experience

Most Likely To Switch

Key Highlights

Extensive experience in GxP compliance and quality assurance.
Proficient in conducting audits for regulatory inspections.
Expertise in Computer Systems Validation and IT governance.

Stackforce AI infers this person is a Quality Assurance and Compliance Expert in the Life Sciences industry.

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Skills

Core Skills

Computer Systems ValidationQuality AssuranceQuality AuditingIt GovernanceAudit ManagementProject Management

Other Skills

21 CFR Part 11AuditingBusiness AnalysisBusiness ProcessBusiness Process ImprovementCAPA ManagementCAPAsClinical Systems AuditsCloud ComputingComputer System ValidationComputerized System ValidationConsultingData IntegrityData Management SystemsDevice Management

About

- Experience in quality and compliance roles for GxP activities (including QA audits particularly CSV/Digital data audits) - Experience participating in regulatory inspections (FDA, MHRA) - Excellent understanding of validation and IT requirements for GxP regulations and guidelines such as Electronic Records and Signatures (21 CFR Part 11), EU Annex 11, ICH-GCP guidelines (Q9/Q10, E6 R2/R3), GAMP 5 guidance. - Familiar with ISO 9001,ISO 27001 and ISO 17025. Specialities: IT Compliance, GxP, GDPR, GAMP 5, Computer Systems Validation (CSV), Computer System Assurance (CSA), Training and E-Learning Course Development, Quality Management System (QMS), Risk Assessment, IT CSV Audit, Data Governance, SOP authoring.

Experience

24 yrs 3 mos

Total Experience

2 yrs 6 mos

Average Tenure

3 yrs

Current Experience

Otsuka pharmaceutical companies europe

CSV auditor

Jan 2024 – May 2025 · 1 yr 4 mos

Kriya therapeutics, inc.

QA Consultant/ Auditor (via Qualtivate)

Jun 2023 – Dec 2023 · 6 mos · Remote

Conducted vendor audits of computerized system, equipment and instrument vendors as per the Annual Audit Program.

Vendor AuditsComputerized System ValidationQuality Assurance

Self-employed

Independent IT CSV Consultant

May 2023 – Present · 3 yrs · Guildford, England, United Kingdom · Remote

Provide interim and project-based QA Services for:
Supplier Management & Supplier Audits
Creation, revision and management of standard operating procedures
Support of external audits and inspections by authorities
Computer Systems Validation (CSV) activities within regulated environments e.g. GCP
Conducting Gap Assessments, GxP Risk and Impact Assessments
CSV related Deviation, CAPA and Change Control Management

Supplier ManagementSupplier AuditsStandard Operating ProceduresExternal AuditsComputer Systems ValidationGxP Risk Assessments+2

Zigzag associates ltd

Senior Lead IT/CSV Auditor

Aug 2022 – Oct 2023 · 1 yr 2 mos · Guildford, England, United Kingdom · Remote

Conduct audits of Clinical Systems (CDMS, CTMS, EDC, eTMF, ePRO, eCOA, IRT), eConsent, Device Management, Cloud Computing, Data Management Systems (IBM CD, Medidata, Oracle InForm) for global clients based in UK, Europe, USA and South Korea.

Clinical Systems AuditsData Management SystemsCloud ComputingDevice ManagementComputer Systems ValidationQuality Auditing