Performing equipment qualifications according to pharmaceutical quality regulations and Dara's internal quality regulations, to ensure the conformity / quality of the facilities and equipment supplied by Dara.
We are looking for validation technicians to carry out the following tasks:
Ensuring the quality of Dara projects.
Write and execute qualifications and protocols of the FDS / DQ, FAT, SAT, IQ / OQ.
Coordinate the quality assurance activities of the assigned projects (internal inspections, FAT, qualifications, ...).
Collaborate in the fulfillment of the planning of the qualification tasks.
Collect, negotiate and reach agreements regarding customer requirements in the qualification protocols. These agreements must contemplate Dara standards, as well as the client's own requirements.
Attend the FAT execution of the assigned projects, together with the client.
Carry out the execution of SAT, IQ and OQ at the client's facilities.
Carry out the continuous improvement of the validation documentation and updating of standards adaptable to each project.
Approval of external protocols, supervision of the contracted works.
Support in the acquisition, maintenance and custody of the documentation regarding pharmaceutical regulations.
Support in the definition, maintenance and filing of the records of the calibration plan of the measuring instruments used in tests.
Provide suggestions and participate in the continuous improvement of the activities carried out.
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