QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

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The candidate will work in a Qualification/CSV project for a Medical Devices manufacturing environment and will be responsible for development and execution of PQ protocols, confirmation runs for each packaging line, development of Completion Reports, review and approval of SOPs. Development and approval of CSV assessment and IOQ protocols. Attend all related meetings, making required document cGMP corrections, and pre-approved/approved changes and following up on document revision and approval.

BACHELOR DEGREE ON COMPUTER OR INDUSTRIAL ENGINEERING OR SCIENCE

5 years+ experience in CSV life cycle; Equipment Qualification for Packaging areas; IQ, OQ, PQ; Validation Plan and Reporting; Protocol Execution

Computer literate; excellent writing skills; bilingual Spanish and English; self starter, team oriented.

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