QA Compliance Specialist

CGxPServe

Posted on : 14-07-2025

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1 Vacancy

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Job Location

Indianapolis, IN - USA

Monthly Salary

Not Disclosed

Salary Not Disclosed

Vacancy

1 Vacancy

Posted on : 14-07-2025

Job Description

Roles & Responsibilities:

GMP Experience.
Minimum 8 years in a GMP-regulated biopharmaceutical environment.
Quality Assurance Experience .
At least 2 years specifically in a QA role.
QA Compliance Knowledge.
Strong knowledge of QA Compliance systems including.
Quality Management Review (QMR).
Annual Product Quality Review (APQR).
Self-inspections.
Audit readiness.
In-depth understanding of FDA/ICH/EU cGMP regulations and guidelines.
Data Integrity.
Experience with Data Integrity principles (ALCOA).

Employment Type

Full-time

Company Industry

Key Skills

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About Company

CGxPServe

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