FAMAR AVE., a leading international service provider in health care industry with activities both in the Greek and the Western European area, seeks to recruit :
QUALITY SYSTEMS OFFICER
The position holder will be required to deliver the following strategic objectives :
Implementation, Maintenance and Improvement of Global Quality Written Procedures Program.
Preparation of regular performance reports and metrics for Quality Management Systems
DUTIES AND RESPONSIBILITIES :
The Quality Systems Officer is responsible for :
The overall coordination of Quality Systems at Global FAMAR level with the implementation, execution, control and completion of the assigned Global Quality Written Procedures ensuring consistency with company strategy, Global Quality requirements, commitments and goals.
In particular : Deployment of Global Quality Systems Tracker for Procedures through :
Identifying & Monitoring in timely manner the needs for Procedures Issuance, Revision, Deletion as per applicable legislative requirements and FAMAR identified needs
Coordinating Written Procedures life cycle management
Establishing criteria for qualified authors and keeping up-to date assigned authors matrix
Consolidation and Preparation of Performance Reports including :
Key Performance Indicators
Monitoring of assigned authors’ qualification expertise
performance reports and metrics for Quality Management Systems
As member of the Global Quality, position holder will contribute to the :
Training delivery of the assigned sessions, as per applicable and as per area of expertise
Authoring and / or reviewing of assigned Quality Written Procedures
FAMAR Quality System as applicable by opening, reviewing and / or approving relevant records (e.g. deviations, CAPAs, Change Controls).
Sites surveillance monitoring mainly in the area of the Quality applied Systems.
Projects related to Quality Systems
PROFILE / SKILLS : Languages :
Fluent in English (advanced oral and written skills).
Italian, Spanish, is an advantage.
Academic Background :
University Degree in Chemistry / Chemical Engineering / Pharmacy / Biology.
Advanced PC skills : (excellent MS skills- especially word, excel, PowerPoint), Good knowledge of Intranet applications like SharePoint as a plus.
Minimum 3 years’ experience in Quality management within the pharmaceutical / healthcare industries (CDMO experience preferred).
Experience in Document Management Systems (e.g. e-doc modules) will be considered as a plus.
Excellent in Technical Writing Skills.
Current knowledge both theoretical and practical aspects of EU Regulations & Directives, Quality Management Systems and processes (ISO 9001, ISO 13485, ISO 22716) as well as comprehensive knowledge of international GMP regulations of medicinal products (knowledge on medical devices, cosmetic, and dietary supplements is preferred)
Qualified / experienced in Documentation Management within Quality functions.
Highly credible both professionally and personally, with an engaging and action orientated approach.
Soft skills on change management, time management, listening & communication, autonomy, self-confidence, problem solving, results oriented, able to work under remote management.
Demonstrated teamwork, collaborative and consensual A colleague that people turn to for advice and want to work with.