GXP Manual Tester

Capgemini

4 - 6 years

4 - 9 Lacs

Bengaluru

Posted:3 weeks ago| Platform:

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Skills Required

Qa Manual Manual Testing Gxp

Work Mode

Hybrid

Job Type

Full Time

Job Description

Perform
manual testing
of applications in
GxP-regulated environments
(GMP, GLP, GCP).
Review and understand
User Requirements Specifications (URS)
and
Functional Specifications (FS)
.
Design and execute
test cases
,
test scripts
, and
test data
based on regulatory and business requirements.
Ensure all testing activities comply with
21 CFR Part 11
,
Annex 11
, and
ALCOA+
principles.
Maintain comprehensive
test documentation
, including
traceability matrices
,
test summary reports
, and
deviation logs
.
Participate in
validation activities
including IQ, OQ, and PQ phases.
Collaborate with QA, business analysts, and development teams to ensure
audit readiness
.
Support
internal and external audits
by providing required documentation and evidence.

Required Skills:

4+ years of experience in
manual testing
with at least 2 years in
GxP-compliant environments
.
Strong understanding of
GMP, GLP, GCP
, and
CSV (Computer System Validation)
.
Experience with
test management tools
(e.g., HP ALM, Jira, TestRail).
Familiarity with
21 CFR Part 11
,
Annex 11
, and
data integrity
standards.
Excellent documentation and communication skills.
Ability to work in a
regulated, process-driven environment
.

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