1) Prepares, writes and reviews validation protocols and documentation to ensure compliance and adherence to cGMP and GLP.
2) Oversees and coordinates the timely calibration and revalidation of manufacturing equipment and instruments.
3) Interface with Engineering, Manufacturing, Facilities, and Quality Assurance to address deviations from the norm, out of tolerances and potential product concerns related to maintenance, calibration, or revalidation issues, define and implement effective corrective actions and monitor post-implementation effectiveness.
4) Works with calibration and validation service providers (vendors/contractors) to coordinate work. Ensures external calibration contractors complete work as required, on-time and with the correct standards., also responsible for external service provider’s evaluation system
5) Maintain and update equipment records in accordance with quality systems requirements.
6) Ensures that all equipment files, documentation and associated databases are kept up to date as part of the calibration/revalidation program.
7) Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of equipments/instruments and prepares documentation for inspection testing procedure.
8) Audits all new equipments documentation manuals to ensure that they are accurate and satisfactory to support operation, maintenance and instruments calibration activities.
9) Oversees implementation of the validation programs. Ensures new equipments are properly validated prior to start up and critical equipment is periodically re-validated.
Skills- Minimum 2 years hands-on relevant experience in compliance & qualification/validation is also required a technical proficiency with pharmaceutical machines.
- Excellent documentation, reporting, communication, organizational skills and very good computer skills.
Must have strong attention to details, learning ability & analytical skills, as well as the ability to work independently and in team environment.
Calibration & Engineering Validation Engineer
Obour City, Cairo, Egypt