The QA QMS Specialist plays a vital role in ensuring robust quality processes and compliance within Unilabs medical services. This position involves managing and maintaining company-wide documentation processes, developing document management policies, and supporting the implementation and management of the online eQMS platform.
Responsibilities:
* Manage and maintain the company's overall documentation processes.
* Develop and implement document management policies and procedures.
* Support the design, implementation and management of online eQMS platform across the group.
* Assist with the eQMS Non-Conformity, Adverse Events and CAPA processes and ensure timely follow-up on action items.
* Manage Change Control documentation and processes.
* Provide training sessions for team members on the documentation processes and eQMS platform.
* Assists in developing, tracking and analyzing key performance indicators and process metrics to measure the performance of the Corporate Quality Management System.
Requirements
Required skills
* Good analytical and problem-solving skills.
* Good interpersonal skills.
* Good communication skills with ability to communicate with internal and external stakeholders.
* Good coordination and planning skills.
* Rigorous, organized and high level of attention to detail.
* Ability to work independently and initiate contacts as necessary.
* Good team player.
Education and Experience
* Bachelor or Master degree (or equivalent).
* Minimum 3-5 year of relevant experience in a Quality position within a life science industry.
* Knowledge of ISO 9001, ISO15189 or ISO 13485 is a plus
* Good MS Office knowledge
* Fluent in English