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Home
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Veeda CR
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IT-QC

IT-QC

Veeda CR

0 - 2 years

2 - 3 Lacs

ahmedabad

Posted:2 weeks ago| Platform:

Apply

Skills Required

gamp 5 21 cfr part 11 eu annex 11 data validation capa change control it sops policies sponsor audits sop documentation alcoa+ principles

Work Mode

Work from Office

Job Type

Full Time

Job Description

Key Responsibilities:

Audit Readiness (IT Focus)

Ensure IT systems, documentation, and infrastructure are
always audit-ready
for external and internal audits.
Lead or support IT-related audit sessions, walk-throughs, and responses during
sponsor audits
,
regulatory inspections
, and
internal QA reviews
.
Maintain an organized repository of IT evidence including
SOPs, validation documentation, access logs
, and
change control records
.

IT Compliance & Documentation

Author, review, and maintain
IT SOPs
,
Policies
etc. in accordance with regulatory requirements.
Ensure that IT documentation complies with
21 CFR Part 11
,
EU Annex 11
, and
GAMP 5
guidelines.
Conduct
periodic reviews
of IT systems and documentation to identify gaps or outdated materials.
Complete the RFI related to IT

Support for Regulated Systems

Work closely with business users, QA, and CRO staff to ensure that electronic records, and data storage systems meet compliance and audit expectations.

Audit Trail & Data Integrity Monitoring

Regularly review
audit trails
,
user access logs
, and
backup records
for critical systems.
Conduct
IT self-inspections
and participate in
internal data integrity assessments
.
Handling the Process related to GDPR
Ensure adherence to
ALCOA+ principles
and manage
risk-based reviews
of electronic systems.

Change Control & Deviation Handling

Participate in
change control
processes involving IT systems and infrastructure.
Investigate and document IT-related
deviations
,
incidents
, and
CAPA actions
in collaboration with QA and stakeholders.

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