Executive-IT
Executive-IT
piramal pharma ltd- Posted 10 hours ago
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Job Description
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Division
Piramal Pharma Solutions
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit : www.piramalpharmasolutions.com
Job Title
Executive-IT
Job Description
IT CSV & GMP Compliance
Key Responsibilities
Manage and maintain IT CSV & GMP Compliance including servers, networks, storage, desktops, and laboratory systems.
Execute and maintain Computer System Validation (CSV) activities for GxP systems.
Ensure compliance with GMP, GDP, GAMP 5, 21 CFR Part 11, Annex 11, and Data Integrity requirements.
Administer user access, audit trails, backup, restoration, archival, and security controls.
Draft and maintain SOPs, validation documents, and compliance records.
Support laboratory applications, business systems, and end-user IT services.
Coordinate with Corporate IT, vendors, and service providers for infrastructure and application support.
Participate in IT projects, system upgrades, validation activities, and regulatory inspections.
Ensure all IT activities are performed as per approved SOPs and quality guidelines.
Division
Piramal Pharma Solutions
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit : www.piramalpharmasolutions.com
Job Title
Executive-IT
Job Description
IT CSV & GMP Compliance
Key Responsibilities
Manage and maintain IT CSV & GMP Compliance including servers, networks, storage, desktops, and laboratory systems.
Execute and maintain Computer System Validation (CSV) activities for GxP systems.
Ensure compliance with GMP, GDP, GAMP 5, 21 CFR Part 11, Annex 11, and Data Integrity requirements.
Administer user access, audit trails, backup, restoration, archival, and security controls.
Draft and maintain SOPs, validation documents, and compliance records.
Support laboratory applications, business systems, and end-user IT services.
Coordinate with Corporate IT, vendors, and service providers for infrastructure and application support.
Participate in IT projects, system upgrades, validation activities, and regulatory inspections.
Ensure all IT activities are performed as per approved SOPs and quality guidelines.
More Info
Key Skills
validation documents
Computer System Validation (CSV)
GxP systems
IT CSV
GAMP 5
GDP
GMP Compliance
Annex 11
compliance records
About Company