13 ago
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Pqe Group
|
Barcelona
13 ago
Pqe Group
Barcelona
Are you ready to join aworld leaderin the exciting and dynamic fields of thePharmaceutical and Medical Device industries ? PQE Group has been at the forefront of these industriessince 1998, with40 subsidiariesand more than2000 employees in Europe, Asia and the Americas.We are currently seeking an experiencedCommissioning, Qualification & Validation (CQV) LeadinBarcelona. This role will focus on the qualification and validation of equipment and systems in biotechnological production facilities.ResponsibilitiesExecutecommissioning, qualification, and validation activitiesfor pharmaceutical/biotech equipment and systemsPrepare, review, and executeC&Q; and validation documentation (URS, DQ, IQ, OQ, PQ protocols, test scripts, and summary reports)Collaborate with cross-functional teams(Engineering, QA, Validation, Manufacturing)to ensure compliance withGMP, regulatory guidelines, and project timelinesReviewtechnical documentation, P&IDs;, FAT/SAT protocols,
and vendor manualsIdentify, troubleshoot, and document deviations, ensuring timely resolutionEnsure all activities meetGMP, FDA, EMA, and ICH requirementsProvide project updates and progress reports to stakeholderQualificationsBachelor’s degree in Engineering, Life Sciences, or related fieldAt least 5 years of experiencein IQ/OQ/PQ protocol development and execution and C&Q; for pharmaceutical/biotech facilities, including construction of production plantsStrong knowledge of GMP, FDA, and EU regulationsExcellent analytical, problem-solving, and communication skillsAbility to work independently and collaboratively in a project environment.Spanish native, English fluent (at least B2)Salary starts from 35.000€ gross per year
📌 Cqv Lead (Barcelona)
🏢 Pqe Group
📍 Barcelona