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Quality Assurance Specialist H/F

Description du job

Mandated by one of our customer, we are seeking a : Quality Assurance Specialist (h/f)

This position supports the Corporate Quality Assurance Manager by establishing and maintaining the Corporate Quality System.

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



 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

We offer

 Fulltime permanent employment in a young working environment and positive culture.