Quality Assurance
il y a 3 semaines
Sterility Assurance & QA Validation Manager
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 at 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 the 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, and mentoring people to ensure growth in technical skills. You ensure 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 Plans, 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, troubleshooting, 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 and develop solutions to reduce quality-related risks.
- You have a Master's degree in Bioengineering, Industrial Pharmacy, Biological Sciences, or related fields.
- You have strong experience in quality systems (non-conformance, compliance, etc.) and GMPs.
- You have a minimum of 5 years of experience in a 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 knowledge of risk management.
- You pay attention to detail, accuracy, and excellent review in a fast-paced environment.
- You have an excellent ability to influence, challenge, and educate the teams in sterility assurance to optimize GMP operations.
- You possess personal credibility, confidence, and robustness to drive and influence colleagues based on rational analysis.
- You are resilient, able to adapt in different environments, and show the ability to multi-task effectively based on priorities.
- You are solution-oriented.
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.
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