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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

Profil

- 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

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