QA Specialist for QC
Jobdescription
For our client Merck in Aubonne, we are looking for aQA Specialist for QC (m / f / d) for a period of 12 months.
Your role :
To ensurethe quality oversight and compliance of QC activities and the dataintegrity of QC analytical data in timelymanner.
QA Oversight on QCanalytical data :
To perform the QAreview on QC analytical data, on QC documentation.
Manage QC deviation, CCP and CAPA asQA.
Compliance of QCactivities :
QA support for QCactivities including new guidelines, new pharmacopeias versions.Support the implementation of all QC projects.
Toperform Quality on the Floor for QCoperations.
Digitalization / ProcessImprovements
Propose and implementdigitalized and more efficient solutions to improve processes inplace within thedepartment.
Responsibilitybackup
Each team member is thereference point of contact for one laboratory. Members of the teamare backing-up each other in case of absence as long as they aretrained to the concernedactivities.
Participation ininspections
Participate in Healthauthorities and internal inspections as Subject Matter Expert andsupport QC laboratories during inspections.
Participate in inspection readiness planning meetings toprepare inspections.
Implement appropriate CAPAplan after inspection.
Yourprofile :
- Chemistry, biology orpharmacy master degree with minimum 3 years of experience inPharmaceutical industry.
- Experience in QualityAssurance. Quality Assurance operation is a plus.
- Expertise in cGMP bestpractices.
- Experience in analytical analysis isa plus.
- Good knowledge on laboratory equipmentand software (like Glims, Empower, Disco ) is aplus
- Fluent in French andEnglish
- Having a team spirit and beingcollaborative are essential.
QA Specialist for QC
For our client Merck in Aubonne, we are looking for aQA Specialist for QC (m/f/d) for a period of 12 months. To perform the QAreview on QC analytical data, on QC documentation. QA support for QCactivities including new guidelines, new pharmacopeias versions. Toperform Quality on the Floor for QCoper...
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