Descripción de la oferta
ppAre you ready to join a bworld leader /b in the exciting and dynamic fields of theb Pharmaceutical and Medical Device industries /b? PQE Group has been at the forefront of these industries bsince 1998 /b, with b40 subsidiaries /b and more than b2000 employees in Europe, Asia and the Americas. /b /p pWe are currently seeking an experienced bCommissioning, Qualification Validation (CQV) Lead /b in bBarcelona /b. This role will focus on the qualification and validation of equipment and systems in biotechnological production facilities. /p h3Responsibilities /h3 ul liExecute bcommissioning, qualification, and validation activities /b for pharmaceutical/biotech equipment and systems /li liPrepare, review, and execute bCQ and validation documentation (URS, DQ, IQ, OQ, PQ protocols, test scripts, and summary reports) /b /li liCollaborate with cross-functional teams b(Engineering, QA, Validation, Manufacturing) /b to ensure compliance with bGMP, regulatory guidelines, and project timelines /b /li liReview btechnical documentation, PIDs, FAT/SAT protocols, and vendor manuals /b /li liIdentify, troubleshoot, and document deviations, ensuring timely resolution /li liEnsure all activities meet bGMP, FDA, EMA, and ICH requirements /b /li liProvide project updates and progress reports to stakeholder /li /ul h3Qualifications /h3 ul liBachelor’s degree in Engineering, Life Sciences, or related field /li libAt least 5 years of experience /b in IQ/OQ/PQ protocol development and execution and CQ for pharmaceutical/biotech facilities, including construction of production plants /li liStrong knowledge of GMP, FDA, and EU regulations /li liExcellent analytical, problem-solving, and communication skills /li liAbility to work independently and collaboratively in a project environment. /li libSpanish native, English fluent (at least B2) /b /li libSalary starts from 35.000€ gross per year /b /li /ul /p #J-18808-Ljbffr
