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FAMAR AVLONAS seeking for R&D QUALITY SYSTEMS OFFICER

FAMAR AVLONAS seeking for R&D QUALITY SYSTEMS OFFICER

R&D Quality Systems Officer

ΕΛΛΑΔΑ – ΑΥΛΩΝΑ N/A

ΠΕΡΙΓΡΑΦΗ ΘΕΣΗΣ ΕΡΓΑΣΙΑΣ

FAMAR is a European contract manufacturing and development partner, for the pharmaceutical and health & beauty industry. Building on our 70 years’ expertise, we deliver flexible solutions, from development to production and distribution. Driven by our customer-care mindset, we offer services covering the majority of pharmaceutical forms, while providing a particularly strong expertise in Liquids, Ointments and Creams. Through the outstanding knowledge and commitment of our 1850 employees and with a network of 6 production sites, we supply a wide range of 1800 products in 125 international markets.

We seek to recruit:  R&D QUALITY SYSTEMS OFFICER  Avlonas BU

SUMMARY:

The position holder will be required to deliver the following strategic objectives:

Development, Ownership, Implementation, Maintenance and Improvement of R&D Quality Written Procedures.

Accountable to generate all the appropriate Quality procedures for ISO13485 & Clinical /Registration batches of the pharmaceutical and health products necessary for the expansion of R&D AVL business

DUTIES AND RESPONSIBILITIES:

The R&D Quality Systems Officer will be responsible for:

The overall coordination of Quality Systems at R&D FAMAR level with the implementation, execution, control and completion of the R&D Quality Written Procedures ensuring consistency with company strategy, Group Quality requirements, legislative & business commitments and goals.

In particular:

Deployment of Group Quality Systems Tracker for Procedures through:

Identifying & Monitoring in timely manner the needs for Procedures Issuance, Revision, Deletion as per applicable legislative requirements and R&D FAMAR identified needs

Coordinating Written Procedures life cycle management

Consolidation and Preparation of Performance Reports including:

Key Performance Indicators

Follow up on quality, safety, business alerts by monitoring the relevant system.

Position holder will contribute to the:

Authoring and/or reviewing of R&D Written Procedures

Opening, reviewing and/or approving relevant records (e.g. deviations, CAPAs, Change Controls).

PROFILE / SKILLS:

Languages:

Fluent in English (advanced oral and written skills).

Greek, Italian, Spanish, is an advantage.

Academic Background:

University Degree in Chemistry/Chemical Engineering/Pharmacy/Biology.

Master in Quality is considered as plus.

Special Knowledge

Advanced PC skills: (excellent MS skills- especially word, excel, PowerPoint)

Good knowledge of electronic documentation & quality management systems will be considered as a plus.

QUALIFICATIONS:

Minimum 2 years’ experience in Quality management within the pharmaceutical/healthcare industries (CDMO experience preferred).

Excellent in Technical Writing Skills.

Current knowledge both theoretical and practical aspects of EU and US 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.

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