Sapes, East Macedonia and Thrace, Greece
119 days ago
Quality Operations Professional (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 attract a Quality Operations Professional to join our Quality Operations team at Pharmathen’s Sapes premises.

As a Quality Operations Professional, you will assure compliance to the GMP standards and ISO requirements. 

More particularly:

What you’ll do:

Ensures the compliance of the Quality Management System’s Requirements according to FDA regulations, EU-GMP regulation and International Standard ISO 9001 and 14001 Be responsible for the description of the codification system of the documents. Develops and executes all the necessary quality activities for the preparation of the proper descriptions on the codification system.  Communicate the appropriate information to all the involved departments in order the new codes to be issued and settled. Keeps the needed records for the monitoring of the notifications and the flow of the process. Implement the needed quality activities for the potential corrections on the codification system Support Regulatory Submission of Dossier. Take part in preparation and authorship of the Quality Management  department’s SOPs,TDRs and other controlled documents of the Quality System of the company. Participate in Quality Oversight activities, Internal & DI audits and customer audits. Handle monitoring, archiving and notification of the main department’s processes including Change Plans, Deviations, CAPAs. Be responsible for Control of the documents and quality records of the Quality System. Update the master list of all documents concerning Quality System.  Perform training sessions on new or revised SOPs. Maintain file of Quality Agreements and Protocols by subcontracted companies and maintains records on this. Participate in all special occasions in regards to the Corporate Quality Management needs and authorizations Participate in media-fill simulation process in aseptic manufacturing area Follow Quality system SOPs in day to day activity Participate in all special occasions in regards to the Corporate Quality Management needs and authorizations

The position is based in either Sapes (Rodopi) or Pallini (Attica),  with frequent travel to Sapes as required to meet operational needs.

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