05 sep
|
Pqe Group
|
Madrid
Are you ready to join a
world leader
in the exciting and dynamic fields of the
Pharmaceutical and Medical Device industries? PQE Group
has been at the forefront of these industries
since 1998 , with
40 subsidiaries
and more than
2000 employees in Europe, Asia and the Americas. We are currently seeking an experienced
Commissioning, Qualification & Validation (CQV) Consultant
in
Barcelona . This role will focus on the qualification and validation of equipment and systems in biotechnological production facilities. Responsibilities
Execute
commissioning, qualification, and validation activities
for pharmaceutical/biotech equipment and systems Prepare, review, and execute
C&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 with
GMP, regulatory guidelines, and project timelines Review
technical documentation,
P&IDs;, FAT/SAT protocols, and vendor manuals Identify, troubleshoot, and document deviations, ensuring timely resolution Ensure all activities meet
GMP, FDA, EMA, and ICH requirements Provide project updates and progress reports to stakeholder Required Qualifications
Bachelor’s degree in Engineering, Life Sciences, or related field At least 2 years of experience
in IQ/OQ/PQ protocol development and execution and C&Q; for pharmaceutical/biotech facilities, including construction of production plants Strong knowledge of GMP, FDA, and EU regulations Excellent analytical, problem‑solving, and communication skills Ability to work independently and collaboratively in a project environment. Spanish native, English fluent (at least B2) Salary starts from 30.000€ gross per year
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📌 CQV Consultant (Madrid)
🏢 Pqe Group
📍 Madrid