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
...
job details
summary
- hyderabad, telangana
- permanent
- job categorycustomer service & call center
job details
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.
show more 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.
experience
5
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. 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. ...
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.
show moreregulated environment.
experience
5share this job.
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