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Quality Assurance Specialist H/F

Description du job

Main tasks
 Analysis and evaluation of monitoring data and key performances indexes in order to insure a continuous
improvement of the quality system
 Complaints management
 Deviation management
 Quality investigations and definition of corrective and preventive actions
 Supplier qualification for finished and semi-finished products, materials, raw materials and their periodic
requalification
 Issuance of Master Batch Records
 Issuance of validation and qualification protocols and reports
 Definition of standard operating procedures and GMP-related documentation along with other involved
units/department Managers
 Definition of training plans for employees along with other involved units/departments Managers
 Execution of batch record review
 Involvement in self-inspections
 Involvement in third parties inspections
 Issuance of GMP related documents (risk analysis, technical reports, etc.)
 Change Control

Profil

Profile
 Bachelor/Master degree in related technical science (Chemistry, Pharmacy or equivalent)
 10 or + years’ experience in the Pharmaceutical field, Production or Quality Assurance (experience gained
preferably in small-medium Pharmaceuticals)
 Knowledge of the pharmaceutical industry (expertise in pharmaceutical manufacturing and GMP procedures
will be considered an asset)
 Expertise in injectables anesthetics (Production)
 Good experience in the use of MS software
 Fluency in French and English will be considered an asset
 Strong relational, communication and adaptability skills
 Ability to work independently and as part of a team
 360° commitment to develop expertise on activities requiring high flexibility
 Able to work independently and as part of a team in order to complete assigned tasks within established
deadlines
 Commitment to continuous improvement