IT -CSV
IT -CSV
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Responsible for developing maintaining and support of computer systems laptops and servers including operating systems office applications.
- Managing the IT Quality System and ensuring GxP compliance is fulfilled
- Support compliance with all GMP/GDP and GxP regulations including Data Integrity compliance
- Maintaining of GMP compliance (Preparation of SOP change control periodic reviews etc)
- Expertise or experience in handling the Pharma software ( QC laboratory instrument software HPLC GC FTIR UV)
- System Owner /Administrator role for GxP IT systems and support the oversight of IT service providers for GxP IT systems
- Provide IT CSV expertise to ensure the continued GxP compliance of all GxPrelevant IT systems and processes
- Prepare Review and approve of computer system validation (CSV) deliverables like Gap Assessment URS Validation Plan Risk Assessment IQ OQ PQ traceability matrix summary report
- Provide IT CSV expertise in Computer System Validation and ongoing compliance processes
- Participate in and lead the compliance review of GxP IT systemrelated change controls
- Provide support for other quality systems including Incident CAPA change management
- Maintain the complete IT inventory management
- Responsible for Data Backup & restore management.
- Planning and maintaining of disaster recovery for server and storage
- To maintain an uptodate knowledge of current industry best practices
- Should have good knowledge on Data integrity electronic signatures 21 cfr part 11
disaster recovery,electronic signatures,pharma software (hplc, gc, ftir, uv),computer system validation (csv),it inventory management,incident management,21 cfr part 11,capa,change control,sop preparation,quality management systems,compliance,it,data integrity,computer system validation,gxp compliance
Employment Type
Full Time
Company Industry
Key Skills
- Computer Hardware
- Network Management
- Active Directory
- LAN
- Firmware
- Computer Networking
- POS
- Windows
- Software Troubleshooting
- Operating Systems
- Micros POS
- Analytics
