Spécialiste, Conformité / Specialist, Compliance

at  Jubilant Pharma Holdings Inc

SPÉCIALISTE, CONFORMITÉ

Jubilant HollisterSiter, une filiale de Jubilant Pharma Holdings Inc., recrute actuellement pour un poste de Spécialiste, Conformité pharmaceutique pour joindre notre équipe !

RESPONSABILITIES

• Performs audits / observations on the different shifts to evaluate the aseptic techniques and behaviors.
• Reviews Media fill videos.
• Maintains the Aseptic observations table and generate the appropriate graphs.
• Manages meetings of the aseptic committee and follow-up on actions.
• Participates in the development of the cleanroom training plan for personnel working in aseptic. Evaluate the training of personnel using the training room.
• Participates to the annual aseptic behaviors training or any other training related to the subject.
• Reviews and approve SOP’s related to the sterile department.
• Performs any other tasks assigned by Management.

EDUCATION, EXPERIENCE AND SKILLS REQUIRED

• BSc – in science, preferably in Microbiology or closely related discipline.
• Microbiology training
• Minimum of five (5) years of experience in pharmaceutical industry with control environment.
• Regulatory and GMP standards
• Strong knowledge of pharmaceutical aseptic techniques and behaviors
• Computer literacy (Microsoft Office & SAP environment)
• Bilingual (French & English).
• Strong interpersonal, organizational and communication skills.
• Excellent communication skills.
  Job Overview

Ensures the compliance of the Sterile Department activities such as the Media Fill program, Personnel Qualification and Environmental Monitoring. Accomplishes this by performing observations / training / audits in order to assess that activities performed in the sterile core meets the internal requirements ofJHS procedures as well as those of regulatory agencies.