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IT -CSV
Global Calcium
posted 7d ago
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Flexible timing
Key skills for the job
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 GxP-relevant 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 system-related 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 up-to-date knowledge of current industry best practices
- Should have good knowledge on Data integrity, electronic signatures, 21 cfr part 11
Employment Type: Full Time, Permanent
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15%
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What people at Global Calcium are saying
What Global Calcium employees are saying about work life
based on 270 employees
Flexible timing
Monday to Saturday
No travel
Day Shift
Global Calcium Benefits
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