Computer System Validation

hace 3 días

Cali, Valle del Cauca, Colombia PQE Group A tiempo completo $30.000 - $60.000 al año

We are a
service provider company
, leader in the
Pharmaceutical
and
Medical Devices
sectors since 1998, with more than
1600 employees
,
45+ nationalities
and
30 subsidiaries
all over the world (Europe, Asia and the Americas). Joining PQE means being a part of a
multicultural
and
challenging
company, with many
local and international projects
, and colleagues from all over the world.

Due to a constant growth, PQE Group is looking for a
Computer System Validation
to work in a project as a
FREELANCER in Cali, Colombia.

About you:


• Very good experience in pharmaceutical industries


• Resolution of fundamental Computer System Validation compliance issues on assigned projects


• Supporting in Writing, reviewing and executing computer validation documentation


• Accountable for the validation of compurterized systems, in accordance with GAMP5 and V-Model (USR, Function Specification, IQ/OQ/Protocol/Report/Testing, Traceability Matrix, Validation Report)


• Good knowledge of Data Integrity Assurance according to EU GMP Annex1, US FDA Annex 11 and relevant predicate guidances


• Capable to assess electronic/paper records aiming to identify Data Integrity gaps with Risk-Based Approach and suggest the most appropriate mitigation/remediation actions


• Ensure all project-related issues and deviations are recorded, approved and dispensed accordingly (including ensuring proper deviation report preparation and approval)


• Support in Preparation of project and life‐cycle reports.


• Ensure all project and lifecycle documents achieve the goal of traceability, and these are all retained in the document repository (Document Navigator) and approved following the prescribed SOP


• Fluent in English (at least B2) *Is a must*

Next Steps

After receiving your application, if a match is found, the Human Resources Department will contact you for an initial interview. If the interview is successful, a technical interview with the hiring manager will be scheduled. If you are successful in the manager interview, the recruiter will contact you to discuss the next steps or our offer. Alternatively, if the outcome is not favorable, we will reach out to inform you that the selection process has concluded.

Working at PQE Group

As a member of the PQE team, you will be part of an inspiring, multicultural company that values collaboration and innovation. PQE Group offers you the opportunity to work on international projects, enhance your skills, and engage with colleagues from around the world. If you are seeking a rewarding and exciting professional career, PQE Group is the perfect place for you. Apply now and take the first step toward an extraordinary future with us.

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