Computer System Validation Engineer

3 weeks ago

Baddi, India PQE Group Full time
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 .

Due to our constant growth, we are looking for a

SeniorCSV Expert

to support our projects in Baddi,

Himachal Pradesh (India) . The resource will collaborate with our Global team and our India team.

You'll Be Responsible For:Analysing

software application

user requirements

and

performing risk assessments

following the CSA approachDeveloping

test cases

and

scripts

according to the risk category of each user requirementExecuting test cases

and gathering relevant evidence for

validationDocumenting

any

deviations

or issues identified during testingPreparing

CSV lifecycle documentation , as neededConducting all activities within the

Polarion CSV tool

in compliance with VMP/ProceduresEnsuring compliance with industry regulations, including

21 CFR Part 11 ,

Annex 11 ,

Data Integrity , and data security standardsCollaborating with global and India-based teams,

ensuring efficient communication and seamless project execution.Execute designed test cases and collect evidence for test execution.Document any deviations/failure during test execution.Prepare

CSV lifecycle documents

(if required).All above activities will be handled within electronic systems (Polarion CSV tool) as per defined VMP/Procedures from the organisation.

About You:A minimum of

5 years of experience

in

Computer System Validation

(CSV), with a focus on GAMP Category 4 and 5 projects.Demonstrated

expertise in validating enterprise applications

and performing risk-based assessments.Strong knowledge

of regulatory standards such as

21 CFR Part 11 ,

Annex 11 , and Data Integrity guidelinesExcellent communication skills

with the ability to work independently and within teamsFlexibility to work onsite or remotely , depending on project requirementsFamiliarity with

Polarion CSV tool

or similar platforms

is

highly desirableAvailability to travelGood knowledge of English

First project you will assigned to

:Location

: India, Baddi,

Himachal PradeshDuration

: 3-6 monthsAvailability

: Full on site

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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