Quality Operations Officer (Rodopi)

Σάπες, Ροδόπης
Μόνιμη
Πλήρης Απασχόληση

Πριν 1 μήνα
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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 Quality Operations Officer to join our Quality team in our Sapes premises.As a Quality Operations Officer the ideal candidate will assure compliance to the GMP standards and ISO requirements.More particularly:What you will do:

Ensure the compliance of the Quality Management Systems Requirements according to FDA regulations, EU-GMP regulation and International Standard ISO 9001 and 14001
Ensure routine presence in manufacturing and packaging areas to support GMP compliance and quality culture
Perform initial review of production and packaging batch records, logbooks, and IPC data for accuracy and GDP compliance
Support and participate in media fill (Aseptic Process Simulation) execution, including documentation, area readiness verification and gowning observations
Assist in the documentation and investigation of deviations, in collaboration with QA specialists or QA operations leads
Collaborate actively with Production, QC, micro, and exports teams to support efficient planning and coordination of batch release activities
Track and support timely closure of open documentation related to release (e.g., logbooks, IPC records, sampling plans).
Take part in preparation and authorship of the Quality Management departments SOPs, TDRs, and other controlled documents of the Quality System of the company
Ensure that all activities are carried out in accordance with applicable SOPs, GMP guidelines, and company quality policies

RequirementsThe ideal candidate should have:

BSc in Life Sciences, Engineering, Pharmacy or equivalent field
Previous experience of 1 - 3 years in a pharmaceutical GMP environment

Job-Specific Skills:

Experience in sterile manufacturing is an asset
Familiarity with production documentation, line clearance, and aseptic practices
Exposure to or participation in media fills is a strong plus
Good written and verbal communication skills in English
Ability to work in a fast-paced, cross-functional environment

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