Pharma IT - Computer System Validation (CSV)

Job summary

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.