Validation Technician

About the Position

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.

Responsibilities

• Ensuring the quality of Dara projects.
• Writing and executing qualifications and protocols of the FDS / DQ, FAT, SAT, IQ / OQ.
• Coordinating the quality assurance activities of the assigned projects.
• Collaborating in the fulfillment of the planning of the qualification tasks.
• Collecting, negotiating, and reaching agreements regarding customer requirements in the qualification protocols.
• Attending the FAT execution of the assigned projects, together with the client.
• Carrying out the execution of SAT, IQ, and OQ at the client's facilities.
• Continuous improvement of the validation documentation and updating of standards adaptable to each project.
• Approval of external protocols, supervision of the contracted works.
• Supporting in the acquisition, maintenance, and custody of the documentation regarding pharmaceutical regulations.
• Supporting in the definition, maintenance, and filing of the records of the calibration plan of the measuring instruments used in tests.
• Providing suggestions and participating in the continuous improvement of the activities carried out.

Requirements

• Proactivity
• Customer Support
• Learning capacity
• Communicative skills
• Attention to detail

Qualifications

• Chemical Engineer
• Chemist
• Industrial Engineer
• Certificate of Higher Education in Chemistry

We Offer

• Time Flexibility
• Catering services

About the Company

Work in the Dara Pharma Group.

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