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Job Description
- Prepares, writes and reviews validation protocols and documentation to ensure compliance and adherence to cGMP and GLP.
- Oversees and coordinates the timely calibration and re-validation of manufacturing equipment and instruments.
- 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 re-validation issues, define and implement effective corrective actions and monitor post-implementation effectiveness.
- 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
- Maintain and update equipment records in accordance with quality systems requirements.
- Ensures that all equipment files, documentation and associated databases are kept up to date as part of the calibration/re-validation program.
- Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of equipment/instruments and prepares documentation for inspection testing procedure.
- Audits all new equipment documentation manuals to ensure that they are accurate and satisfactory to support operation, maintenance and instruments calibration activities.
- Oversees implementation of the validation programs. Ensures new equipment are properly validated prior to start up and critical equipment is periodically re-validated.
Job Requirements
- 1-4 years of experience in 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.
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