- Write and review computer system validation SOP and documentation (Protocols and reports).
- Maintain accurate validation documentation
- Train other staff members on the correct use of computerized systems in line with protocols and regulations
- Involvement in review and updating of validation documentation
- Participate in Validation Risk Assessments to determinate the level of testing required for new software.
- Involvement in review and updating of validation documentation
- Review and analyze validation data - compiling reports when required
- Recommendation and implementation of process upgrades and improvements in efficiency
- Involvement in both internal audits and external inspeccions (FDA, EMA and INVIMA)
- Raising, supporting and resolving validation deviation as they occur.
- Professional in Sciences (Life Sciences) Engineering, Chemistry, Pharmacist, Biotechnology, Biochemistry or equivalent.
- Experience in validation / qualification processes in Pharma Industry / cGMP rules and regulation / Excel tools knowledge. Desirable knowledge in FDA and EMA regulations.
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201144-It Computer System Validation Specialist - Antioquia, Colombia - Seguros Sura
Descripción
Main Purpose of the Role:
Computer System Validation Specialist is responsible for carrying out tests and validation studies of computerized systems.
Plan, write, implement and review computer system validation protocols and report results to make sure that all cGXP computer-based systems are operating as intended.
Responsibilities:
