Job Description
As a member of the Quality System & Compliance group, your role involves acting as the process owner for change control and risk quality processes.
You will be responsible for ensuring that these processes are designed, implemented, and maintained in accordance with regulations and industry standards.
Key Responsibilities:
* Ensure effective implementation and maintenance of change control and risk quality processes.
* Oversee the integration of these systems into all aspects of site operations.
* Conduct regular monitoring and analysis of system performance.
* Provide support during inspections and audits as process owner.
Additional Responsibilities:
* Support the continuous improvement of site Quality Systems.
* Act as Key User and administrator of computerized Quality management systems (back-up).
* Implement new regulatory or Quality standards and/or quality systems requirements.
* Support continuous improvement in digital transformation and digital roadmap.
* Support Quality and Performance metrics.
Projects:
* Automatization of routine tasks (with tools like Power Apps, Power Automate) and processes.
* Continuous improvement of area under your responsibilities.
* Contribute to site digitalization roadmap and future eQMS.
Your Profile:
University degree (min Bachelor) in scientific education.
5+ years of experience in the pharmaceutical industry, including Quality Systems management and manufacturing processes.
Experience in change control/risk management.
Experience in Health Authorities Inspections is a plus.
Digital mindset and knowledge, promoting continuous improvement and innovation.
Ability to drive collaborations with cross-functional teams, demonstrating good project management skills.
Personal accountability for results and integrity, with a solution-based thinking and risk-based approach.
Strong organizational skills, including time management and planning, with fluency in French and English.