Sterility Assurance & QA Validation Manager

at  Trasis

As a Sterility Assurance and QA Validation Manager , you are responsible for the QA validation, qualification and CSV execution and oversight to ensure the Quality of these areas Trasis Group. You ensure that both internal sterility assurance standards and external regulatory standards and guidance are comprehensively understood and effectively applied throughout the organization.

Responsibilities

• You are the reference for the sterility assurance and QA validation aspects of a project related to implementation of a filling-lyophilization line for aseptic operations. You are part of the project team as the QA representative for the validation strategy of the aseptic operations. You are the QA operational lead for all validation documentation related to the project.
• You define lean and agile validation strategy and policy of Trasis Group. You execute the site’s Sterility Assurance Strategy, Sterility Assurance roadmap and Practices in collaboration with other Business Stakeholders.
• You manage the QA qualification, validation, CSV team, through performance management, planning, coaching, mentoring people to ensure growth in technical skills. You ensures team spirit and a climate of collaboration and trust within the department.
• You define and ensure performance indicators (KPI’s) related to qualification, validation, CSV and sterility assurance
• You review and manage the validation deliverables such as Risk Assessments, Validation/Qualification Plan and respective protocols/reports.
• You act as the primary point of contact for sterility assurance and validation across all areas of the business, including departments such as Operations, Infrastructure, Industrialization, R&D and Quality Control (QC).
• You support Business Units in the execution of the CCS in the different sterility assurance domains and processes (training, trouble shooting, coaching/mentoring, specific projects). You are accountable for alignment in way of working and standard works between Business Units in Sterility Assurance subjects.
• You support the development and implementation of an inspection readiness program with the contribution of other stakeholders.
• During external audits and inspections, you are the Subject Matter Expert regarding strategy and quality assurance of Qualification/Validation/CSV and Sterility Assurance matters. You lead remediation plans following any regulatory observations
• You regularly GEMBA the Aseptic Practices and Environmental Monitoring Practices on the shop-floor to ensure adherence to implemented Standard Practices, Processes and Systems by all site personnel
• You ensure adequate deviation investigation (impact assessment and root cause analysis), define and support implementation of CAPA and Change Control. You analyze and escalate the business risks. You develop solutions to reduce quality-related risks.

Profile

• You have a Masters degree in Bioengineering, Industrial Pharmacy, Biological Sciences or related fields.
• You have a strong experience in quality systems (non-conformance, compliance, etc.) and GMPs.
• You have minimum 5 years of experience in similar role in the pharmaceutical industry.
• You have experience in team management.
• You are able to work in English in addition to French.
• You have a good knowlegde in risk management.
• You pay attention to detail, accuracy and excellent review in a fast-paced environment.
• You have excellent ability to influence, challenge and educate the teams in sterility assurance to optimize GMP operations.
• Personal credibility, confidence and robustness to drive and influence colleagues based on rationale analysis
• You are resilient, able to adapt in different environment, show ability to multi-task effectively and based on priorities.
• You are solution oriented.

Do you want to become a major player in the global fight against cancer?
At Trasis, we give you the opportunity to work with cutting-edge technologies and to contribute to the improvement of cancer diagnosis and therapy techniques. Through your actions, you will have the opportunity to have a positive impact on the services provided to users and patients.
The opportunity to participate in building and improving processes in a growing company.
We offer a young and friendly work atmosphere, a flexible and dynamic environment.
An attractive and flexible salary according to your experience and performance, with extra-legal benefits

• You are the reference for the sterility assurance and QA validation aspects of a project related to implementation of a filling-lyophilization line for aseptic operations. You are part of the project team as the QA representative for the validation strategy of the aseptic operations. You are the QA operational lead for all validation documentation related to the project.
• You define lean and agile validation strategy and policy of Trasis Group. You execute the site’s Sterility Assurance Strategy, Sterility Assurance roadmap and Practices in collaboration with other Business Stakeholders.
• You manage the QA qualification, validation, CSV team, through performance management, planning, coaching, mentoring people to ensure growth in technical skills. You ensures team spirit and a climate of collaboration and trust within the department.
• You define and ensure performance indicators (KPI’s) related to qualification, validation, CSV and sterility assurance
• You review and manage the validation deliverables such as Risk Assessments, Validation/Qualification Plan and respective protocols/reports.
• You act as the primary point of contact for sterility assurance and validation across all areas of the business, including departments such as Operations, Infrastructure, Industrialization, R&D and Quality Control (QC).
• You support Business Units in the execution of the CCS in the different sterility assurance domains and processes (training, trouble shooting, coaching/mentoring, specific projects). You are accountable for alignment in way of working and standard works between Business Units in Sterility Assurance subjects.
• You support the development and implementation of an inspection readiness program with the contribution of other stakeholders.
• During external audits and inspections, you are the Subject Matter Expert regarding strategy and quality assurance of Qualification/Validation/CSV and Sterility Assurance matters. You lead remediation plans following any regulatory observations
• You regularly GEMBA the Aseptic Practices and Environmental Monitoring Practices on the shop-floor to ensure adherence to implemented Standard Practices, Processes and Systems by all site personnel
• You ensure adequate deviation investigation (impact assessment and root cause analysis), define and support implementation of CAPA and Change Control. You analyze and escalate the business risks. You develop solutions to reduce quality-related risks