Quality assurance specialist H/F

Description du job

Quality Assurance Specialist H/F
Essential tasks and responsibilities :

Editing and issuance of qualification documents as well as final reports and GMP related
documents (risk analysis, technical reports, etc.)
Execution of qualification of equipment, utilities and machines, process validation and
cleaning validation processes
Analysis and evaluation of KPI and data monitoring to ensure a continuous improvement of the quality system
Deviation and Change Control management
Quality investigations and definition of corrective and preventive actions
Definition of Standard Operating Procedures (SOP) and GMP-related documentation along with other relevant units/ department Managers
Contribution to the implementation of innovative industrial Projects.
Involvement in self-inspections and in third parties inspections
Drawing of validation protocols, and final validation and qualification reports
Definition of staff training plans and coordination of training and education activities.
Cooperation with production and maintenance to define Gantt of shutdown activities and in
general Gantt for qualification activities in order to have close alignment.
More specifically, the position includes the following tasks:

Plan and coordinate validation activities in collaboration with the concerned department
manager.
Develop and maintain relationships with external validation service suppliers and planning
their interventions.
Based on the documentation, deliver Training to employees who are involved in validation
activities.
Participate to issue the Validation Master Plan and the Validation Project Plans related tothe industrial projects.
Accomplish planned validation tasks, with the support of external or internal staff.
Assure that the installation of new machines and utilities is performed according to relevant
documentation (QD, IQ, QO, etc.).

Profil

Required skills and core competences

Bachelor/Master degree in technical scientific subjects (Chemistry, Pharmacy, Engineering
or equivalent)
5 years' experience in the pharmaceutical field, production, or quality assurance
Expertise in injectables anesthetics (Production) and terminally sterilized products will be
considered an asset.
Good knowledge of the pharmaceutical industry and expertise in pharmaceutical
manufacturing and GMP procedures will be considered an asset
Fluent in spoken and written Italian and English, knowledge of French will be considered
an asset.
Excellent communication skills, proactivity, autonomy, precision, teamwork aptitude.
Management and organizational skills, flexibility, learning agility and strategic thinking.
Commitment to continuous improvement.
Preference will be given to candidates of Swiss nationality and residents (Permit B -C)


Louise Terzo

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