Senior Quality Associate​/Associé principal; e), Assurance qualité

Position: Senior Quality Associate/ Associé principal (e), Assurance qualité
* Management of Quality Assurance projects with a focus on compliance, productivity, and improvement of quality metrics. Leads these teams through project planning, organization and tracking of project deliverables.
* Preparation of risk assessments, protocols, Standard Operating Procedures, training materials and gap assessments.
* Work closely with Quality Assurance stakeholders on multidisciplinary projects that require quality consultation; this may include management of multi-stakeholder projects that directly influence compliance and manufacturing outcomes.
* Complete Technical and Quality Agreements.
* Work closely with Quality Assurance stakeholders to provide input into protocol development and to ensure protocols are compliant with our company's and GMP standards.
* Review and approval of executed validation / qualification protocols and reports.
* Manage Quality Assurance regulatory and internal inspection preparation. Participates in a lead support role during inspections.
* Conducts site self-inspections and Quality Assurance walkthroughs.
* Release of equipment and facilities.
* Supporting the implementation of our company's Animal Health Quality Manual as required.
* Shared responsibility for the following quality systems: change controls, quality events and investigations, Corrective and Preventative Actions, and out of specification.
* Provides initial assessment of quality events, investigations, Corrective and Preventative Actions, and OOS for completeness and compliance.
* Leads cross functional teams (when required) in investigations and analysis to determine root cause and aids in the resolution of issues.
* Provides initial assessment of quality events, investigations, Corrective and Preventative Actions, and OOS for completeness and compliance.
* Leads cross functional teams (when required) in investigations and analysis to determine root cause and aids in the resolution of issues.
* Involves site subject matter experts for final assessment and closure.
* Approves deviations
* Preparation and approval of change controls and impact assessments
* Tracking and trending of all systems to ensure timely closure and follow up where required.
* Other duties as required.
* Minimum of a Bachelor of Science degree or equivalent.
* At least 5 years in Quality Assurance and or current Good Manufacturing Practices facility operation experience.
* Cross functional collaboration experience with multiple teams (indirect or direct leadership experience is an asset)
* Proven ability to work independently due to the highly independent nature of this role.
* Focused on achieving goals and persistent when faced with obstacles.
* Adaptable to quick changes in required activities or duties.
* Thinks critically to support the needs of Quality Assurance but also considers business impact.
* Excellent communication skills, in both verbal and written form.
* Language requirement:
English
* Proficiency with business applications such as Adobe, MS Office, Word, Excel, Access, Project, Visio, and PowerPoint.
* General knowledge of regulatory requirements for the pharmaceutical, biotechnology, or vaccine industry required.
* Good problem-solving skills.
* Experience in root cause analysis.
* Work effectively in cross-functional teams.
** Secondary*
* ** Language(s)

Job Description:

*** Gestion des projets d’assurance qualité axés sur la conformité, la productivité et l’amélioration des indicateurs qualité. Dirige les équipes via la planification, l’organisation et le suivi des livrables.
* Préparation des évaluations de risques, protocoles, procédures opérationnelles normalisées, supports de formation et analyses des écarts.
* Collaboration avec les parties prenantes en assurance qualité sur des projets multidisciplinaires nécessitant une expertise qualité, incluant la gestion de projets multi-acteurs influençant directement la conformité et les résultats de fabrication.
* Rédaction et finalisation des accords techniques et qualité.
* Contribution au développement des protocoles et vérification de leur conformité aux normes internes et GMP.
* Revue et approbation des protocoles et rapports de validation/qualification exécutés.
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