Role Overview
This role supports and controls the management of controlled documents at the KSP facility, ensuring compliance with QMS requirements. The successful candidate will be responsible for managing complaints and supplier changes within the quality management system.
Key Responsibilities
* Control and issue master documents, including allocation of document numbers and maintenance of QA logs.
* Create and store executed batch documents, ensuring timely archiving and security.
* Maintain QualDocs DCG user roles, checking documents and creating Document Change Control as required.
* Support projects and facilitate supplier/vendor change notifications throughout the business.
* Collate metrics and KPI data, reporting on Off-site Archiving, DCC rejections, and overdue documents.
Required Skills and Knowledge
* Working knowledge of Microsoft Word and Excel.
* Organized approach to documentation with attention to detail.
* Patient and determined individual with a scientific background (desired).
* Good communication and interpersonal skills.
* Knowledge in GMP or Quality Systems (desired).
Attributes and Behaviors
* Proven organizational and interpersonal skills, demonstrated through competencies such as customer focus, integrity and trust, peer relationships, functional/technical skills, time management, action orientation, organizing, listening, approachability, and informing.
Education and Experience
* Secondary school education completed.
* Typically 4+ years of relevant work experience in Pharmaceutical, Biotechnology, or a related industry.