Pharma IT

Job summary

As a Pharma IT - CSV, you will be responsible for the validation of all GxP-relevant computerized systems used across manufacturing, quality control, and R&D. Your role is critical in ensuring all IT systems meet regulatory requirements from agencies like the US FDA, MHRA, and others. You will manage the entire system validation life cycle, from planning to retirement, within a highly regulated pharmaceutical environment.

Responsibilities

• Validation life cycle: Plan, execute, and document computer system validation activities in accordance with GAMP5 guidelines and internal Standard Operating Procedures (SOPs).
• Regulatory compliance: Ensure all computerized systems and processes adhere to regulatory requirements, particularly 21 CFR Part 11, EU Annex 11, and other applicable GxP regulations.
• System management: Oversee the data and user management activities for critical laboratory and manufacturing systems, including PLC, SCADA, HMI, and Empower Chromatography software.
• Validation deliverables: Prepare and review validation documents, including Validation Plans, Requirements Specifications, Test Scripts, and Summary Reports.
• Change control: Handle IT-related Change Controls, Deviations, and CAPAs, performing impact assessments and ensuring all changes to validated systems are properly documented and approved.
• Backup and restoration: Ensure all backup and data restoration procedures for Empower, stand-alone, and other computer systems are validated and routinely tested for data integrity.
• Access control: Manage user access and assign privileges for various software systems (e.g., LMS, DMS, CAP, Empower) to maintain security and data integrity.
• Audits and inspections: Participate in internal and external regulatory audits (e.g., US FDA, MHRA), provide necessary documentation, and prepare audit responses related to computerized systems.

Qualifications and skills

• Proven experience in Computer System Validation within the pharmaceutical or life sciences industry.
• In-depth knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11.
• Strong understanding of GxP regulations (Good Manufacturing Practices) and data integrity principles.
• Familiarity with laboratory software (e.g., Empower, LIMS) and manufacturing automation systems (e.g., SCADA, PLC).
• Excellent technical writing and documentation skills.
• Strong analytical and problem-solving abilities.