QMS Officer (Rodopi)

Σάπες, Ροδόπης
Μόνιμη
Πλήρης Απασχόληση

Πριν 2 μήνες
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Founded in 1969, Pharmathen has grown to become one of the largest, vertically integrated developers of complex drug delivery technologies and is among the top 50 pharmaceutical research companies in Europe.The company has one of the most extensive and advanced pipelines of long acting injectables (LAI), sustained release and ophthalmic formulations.Pharmathen’s highly diversified portfolio consists of over 90 commercialized products, which are produced in its US FDA and EU-approved manufacturing facilities in Greece, serving 250 customers and accessed by patients in more than 90 countries worldwide.Pharmathen proudly employs more than 1,600 people from over 28 different nationalities, with 54% of its total workforce and 66% of its Research Operations Team being female. The company’s enduring success is attributed to a passion for creativity, strong ethics, and the dedication of its people, who share a commitment to the company's vision of making a difference in people’s lives.Due to continuous growth and expansion, Pharmathen Pharmaceuticals offers a great opportunity for career development and is seeking to recruit a QMS Officer to join our QMS team in our Sapes premises.As a QMS Officer you will be responsible for assuring compliance with GxP standards and ISO requirements within all activities performed at BU Sapes and provide guidance to all involved departments of the facility.More particularly:What you will do:

Overview and monitore the organization GMP activities
Ensure compliance of Quality Management System’s Requirements according to EU GMPs, FDA guidelines, ISO standards and company’s Standards Operating Procedures and Policies
Work in accordance with the requirements of the written Policies, Standard Operating Procedures, Technical Directives and Protocols of the company's Quality System, that are related to the duties of the described position
Coordinate Change Control Management system in EQMs for LAI / OSD products
Communicate with customers for change control notifications, approvals as required as per Standard operating procedures and Quality Technical Agreements
Communicate internally and with customers regarding any quality queries related to facility activities
Access and use of the software provided by ΙΤ of company and is related to their work as, eQMS, Training Tools and Systems, e-signature tools
Coordinate, handle Documentation module in EQMs and paper based
Support quality EQMs modules such as “CAPA”, “DIR”, “LMS” etc.
Coordinate training process
Prepare/monitore quality metrics, KPI, related to Change Control, Documentation, Training module
Take part in the authorship of the department’s SOPs, TDRs, protocols, and any other kind of controlled quality document.
Support customers audits/authorities’ inspections, regarding Documentation, Change control requests, training
Develop quality documents in compliance with the registered and approved product review
Be QA coordinator for GxP training, database and archiving as per respective SOP

RequirementsThe ideal candidate should have:

Bsc. Desirable Bsc in chemistry, pharmacy, chemistry engineer or equivalent
Desirable 1-2 years’ experience in Quality Management or relevant department

Job-Specific Skills

Excellent communication in English language (writing & speaking)
Computer literacy
Ability to prioritize tasks and meet deadlines
Exceptional communication skills, strong project management skills

BenefitsWhat you'll gain:

Involvement in a high-caliber, team-oriented and dynamic atmosphere
Exposure to challenging business issues and practices
Great opportunity to leverage and develop your business knowledge and skills

Join our team and experience the unique Pharmathen’s culture that gives you the opportunity to innovate, to make decisions, to achieve your own potential and to chart your own career.Pharmathen is an equal opportunity employer. We welcome applications regardless of gender, race, age, religion, sexual orientation, and national origin

Pharmathen