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Quality Assurance Specialist

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Quality Assurance Specialist
Description du job

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
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
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


Bachelor/Master degree in related technical science (Chemistry, Pharmacy or equivalent)
5-7 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) and terminally sterilized products
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
Availability to travel

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