Sapes, East Macedonia and Thrace, Greece
35 days ago
QMS Officer (Rodopi)

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

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