CSV Enginner
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Job Location:
Monthly Salary:
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Plan execute and document Installation Qualification (IQ) Operational Qualification (OQ) and
Performance Qualification (PQ) activities for computerized systems and infrastructure supporting
GMP/GxP operations.
Ensure all validation activities are performed in accordance with approved procedures industry
standards (e.g. ISPE GAMP 5) and regulatory expectations.
Execute IQ/OQ protocols for IT infrastructure including servers networks and laboratory
systems ensuring systems are fit for intended use and compliant with data integrity requirements.
Performance Qualification (PQ) activities for computerized systems and infrastructure supporting
GMP/GxP operations.
Ensure all validation activities are performed in accordance with approved procedures industry
standards (e.g. ISPE GAMP 5) and regulatory expectations.
Execute IQ/OQ protocols for IT infrastructure including servers networks and laboratory
systems ensuring systems are fit for intended use and compliant with data integrity requirements.
Required Skills and Qualifications
In-depth knowledge of CSV principles IQ/OQ/PQ protocols and pharmaceutical regulatory
requirements (e.g. FDA 21 CFR Part 11 EU GMP Annex 11 ISPE GAMP 5).
Experience with IT infrastructure qualification data integrity assessments and audit trail review
processes in a GMP/GxP environment.
Strong documentation skills and experience supporting regulatory inspections and audits.
Excellent organizational analytical and communication skills with the ability to collaborate
across multidisciplinary teams.
Demonstrated ability to manage multiple projects prioritize tasks and meet deadlines in a
regulated environment.
In-depth knowledge of CSV principles IQ/OQ/PQ protocols and pharmaceutical regulatory
requirements (e.g. FDA 21 CFR Part 11 EU GMP Annex 11 ISPE GAMP 5).
Experience with IT infrastructure qualification data integrity assessments and audit trail review
processes in a GMP/GxP environment.
Strong documentation skills and experience supporting regulatory inspections and audits.
Excellent organizational analytical and communication skills with the ability to collaborate
across multidisciplinary teams.
Demonstrated ability to manage multiple projects prioritize tasks and meet deadlines in a
regulated environment.
