Jobdescription
Location: Bulle,Switzerland
Activity rate :100%
Type of contract: Temporarycontract
Start Date:01.02.2025
End Date: 31.12.2025 (with a potentialextension)
Are you passionateabout ensuring the reliability and compliance of equipment in thepharmaceutical industry? We're looking for a meticulousQualification Specialist to take the lead in qualifying GMPinstallations, equipment, and utilities.
Keyresponsibilities:
* Define the globalqualification strategy
* Lead and writequalification risk assessments
* Writequalification plans, protocols andreports
* Ensure the correct qualification of GMPinstallations (including equipment, software, logic controllers andutilities)
* Maintain and update the planning ofqualification activities
* Ensure thecoordination of qualification activities with externalpartners
* Perform the periodic requalificationof utilities in collaboration with authorized externalsubcontractors
* Write and update the QMF(Qualification Master File) and PQR (Product Quality Review)documents
* Improve qualification processes anddocumentation
* Ensure adherence to projecttimelines and lead qualification projects
* Actas SME in cross-functional and qualification-relatedinitiatives
* Comply with cGMP standards andmaintain accurate documentation
* Provide SMEinput on deviations, Change Controls, andaudits
* Apply HSE policies, report incidents,and promote safety culture
Qualifikationen
What will make yousuccessful:
* An Engineering diploma(Preferably in life science)
* Over 3 years ofexperience in pharmaceutical and/or biotech manufacturing,including work in controlled areas
* Provenexpertise in qualification of installations and systems, within-depth knowledge of cGMPs and relatedregulations
* Experience in leading qualificationstrategies and defining qualificationplans
* Strong planning, organizational, andproblem-solving skills, with the ability to workautonomously
* Excellent communication skills anda collaborative mindset, with a solution-oriented and pragmaticapproach
* Proficient in MS Office tools andbasic statistics
* Fluent in French and English,spoken and written