Spécialiste Conformité Production / Production Compliance Specialist

Montréal, QC, CA, Canada

Job Description

Below the english version

1. OBJECTIFS DU POSTE

Participer a la planification et a l'organisation de la production afin d'assurer le bon deroulement des operations.

Gerer les differents dossiers de production et veiller particulierement au respect de la conformite de la documentation, des processus de fabrication ainsi que des normes de sante et de securite au travail.

2. PRINCIPALES FONCTIONS

Supporter l'equipe de supervision dans la mise en place des initiatives d'amelioration et d'optimisation des processus, de la documentation et des equipements en place (CAPA, projet, etc.). Participer a l'amelioration et l'optimisation des processus de production et a la realisation des taches reliees aux systemes qualite (CAPA, CCF, etc.) afin de supporter les operations steriles. Consulter les principaux intervenants de facon a operationnaliser leurs requis et les besoins du plancher. S'assurer que toutes les mesures correctives sont implantees et suivis selon les requis dans le temps. Assurer une presence pro-active sur le plancher de production pour assurer la conformite des registres et autres documentations selon les procedures en place et les bonnes pratiques de fabrication et de documentation. Collaborer avec les departements support pour la planification et la coordination des activites de maintenance, de validation, de formation et l'assignation du personnel/materiel necessaire a leur execution. Peut-etre appele a initier les non-conformites lorsque requis et prendre les actions requises afin de minimiser l'impact sur la qualite des produits. Participer aux investigations au besoin. Effectuer toute autre tache connexe jugee pertinente dans le cadre du poste.
3. EXIGENCES ET APTITUDES

Baccalaureat en Sciences ou toute autre experience jugee pertinente. Minimum de 5 ans d'experience dans l'industrie pharmaceutique, dont au moins 3 ans en fabrication de produits injectables. Solide connaissance et comprehension des processus de fabrication de produits injectables et des Bonnes Pratiques de Fabrication et de Documentation. Leadership, initiative, debrouillardise et autonomie. Sens de l'organisation et oriente vers la qualite et les resultats. Capacite a gerer les priorites et a travailler sous pression avec des echeanciers serres et des changements frequents de priorites. Aptitudes en resolution de problemes et en communication interpersonnelle. Esprit d'analyse et de synthese et sens du jugement. Esprit d'equipe et habilite a travailler dans des equipes multidisciplinaires
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1. JOB OBJECTIVES

Participate in production planning and organization to ensure smooth running of operations.

Manage the various production files and pay particular attention to compliance with documentation, manufacturing processes, and health and safety standards.

2. PRIMARY FUNCTIONS

Support the supervisors in implementing initiatives to improve and optimize processes, documentation and equipment (CAPA, projects, etc.). Participate in improving and optimizing production processes and performing tasks related to quality systems (CAPA, CCF, etc.) to support sterile operations. Consult with key stakeholders to implement their requirements and floor needs. Ensure that all corrective measures are implemented and followed up on as required in a timely manner. Maintain a proactive presence on the production floor to ensure that records and other documentation comply with established procedures and good manufacturing and documentation practices. Collaborate with support departments to plan and coordinate maintenance, validation, and training activities and assign the personnel/equipment necessary for their execution. May be called upon to initiate non-compliance procedures when required and take the necessary actions to minimize the impact on product quality. Participate in investigations as needed. Perform any other related tasks deemed relevant to the position.
3. EXPERIENCE REQUIREMENT AND APTITUDES

Bachelor's degree in Science or any other relevant experience. Minimum of 5 years of experience in the pharmaceutical industry, including at least 3 years in the manufacture of injectable products. Solid knowledge and understanding of injectable product manufacturing processes and Good Manufacturing and Documentation Practices. Leadership, initiative, resourcefulness, and autonomy. Organizational skills and a focus on quality and results. Ability to manage priorities and work under pressure with tight deadlines and frequent changes in priorities. Problem-solving and interpersonal communication skills. Analytical and synthesis skills and good judgment. Team spirit and ability to work in multidisciplinary teams.
Type d'emploi : Temps plein, Permanent

Lieu du poste : En presentiel

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Job Detail

  • Job Id
    JD2837746
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Montréal, QC, CA, Canada
  • Education
    Not mentioned