The Quality Compliance Officer for Cytiva is responsible for:
61 Maintain site compliance and certification status.
61 Maintain a healthy quality management system at site and stay aligned with other global sites.
61 Ensure site team’s compliance with both internal & external quality training requirements.
61 Stay connected with global QARA community to implement changes and drive improvement.
In this role, you will have the opportunity to:
61 Host external audits including customer audits and audits by regulatory bodies, responsibilities include audit scheduling, site introduction, organizing local SMEs to respond to audit questions, receipt of audit reports, providing site response, follow up on findings and observations till closure.
61 Organize site internal audits and host corporate level audits. Track all audit findings till closure.
61 Create and manage audit records in company system for both external and internal audits.02
61 Take responsibility for QMS implementation at site, use audits and gemba walks to drive improvement.02
61 Own quality documentation and document control covering document creation, modification and revision, till document obsolescence.02
61 Be the site administrator for quality training, provide training and communication to the site team to ensure that quality training requirements are met, and site quality training plan & records are maintained.
61 Report out on audit, QMS and training related KPIs.
61 Support quality related projects and activities.
The essential requirements of the job include:
61 3+ quality management system experience with a Bachelor degree in a scientific field, preferable in Lifesciences (biomedical, chemistry, pharma,…)
Skills:
o Language: English (written & spoken)
o Strong working knowledge of quality management system
o Familiarity with ISO9001
o Experience in a regulated industry preferred
o Good working knowledge of MS Office software
It would be a plus if you also possess previous experience in:
61 Knowledge of ISO 13485 a plus02
61 Track record of successful external audit hosting.
61 Strong interpersonal and communications skills
61 Excellent planning, organization, and presentation skills02
61 Fast learner with good cross functional leadership capabilities
61 Ability to multi-task, solve problems and make decisions
61 Works collaboratively with other functions