Qualification and Validation Manager

Job Description

The Qualification and Validation Manager support the equipment managers with all quality-related issues. They are the approval authority for test and maintenance regulations, as well as the documents for equipment qualifications, method validations and method transfers.

Critical Performance Areas

■    Support the correct processing of equipment qualifications, method validations and transfers.

■    Maintain the master data of all equipment in the LIMS and provide the Operations with the current master data sheets.

■    Perform all related tasks and duties for the company-wide monitoring and alarm system (room, air conditioning and cooling device monitoring).

■    Coordinate and carry out maintenance work by external service providers for the cooling and air conditioning units (calibration/replacement of sensors, mapping).

Essential Job Functions

■    Support the employees of the business units in qualifying devices, and create qualification plans and reports for business unit devices

■    Coordinate work on equipment qualification

■    Coordinate external partners for device qualifications

■    Support the employees of the business units in validating methods

■    Standardize the procedure for validating methods

■    Assist as needed with release of quality documents and collaboration in QA training and audits

NOTE: This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.

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