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.
- Customer Support
- Learning capacity
- Communicative skills
- Attention to detail