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Consultor desarrollo

Castro Caldelas (32774)
PQE Group
Desarrollador informático
Publicada el 2 abril
Descripción

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 include, but are not limited to: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

stakeholders

.

Required Qualifications:Bachelor's degree

in

Engineering, Life Sciences

, or related field.At least 1 year of experience

in

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 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)

Next StepsUpon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.If there's a positive match, a technical interview with the Hiring Manager will be arranged.In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

Working at PQE GroupAs a member of the PQE team, you will be part of a

challenging, multicultural company that values collaboration and innovation

. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.Apply now and take the first step towards an amazing future with us.

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