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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 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


• 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