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 Supplier Quality Operations Officer for the Corporate Quality Management team in our Marousi premises.
As a Supplier Quality Operations Officer, you will be responsible for ensuring compliance with cGMP requirements and ISO standards.
More particularly:
What you will do:
Ensure the compliance of the Quality Management System’s Requirements according to cGMPs and International Standard ISO 9001 Participate in the company’s Supplier and service provider qualification program. Support the processes for selecting, qualifying, disqualifying and periodically evaluating Suppliers and Service Providers of Pharmathen, ensuring compliance with applicable regulations and cGxP requirements Handle and monitor supplier and service provider’s complaints Handle and oversee suppliers and service providers' notifications Compilation, issuance and maintenance of External Supply Quality audit plan Schedule of suppliers and service providers audits, support the External Supply Quality Audit Team Follow up external Suppliers CAPA plans and their closures Escalate External suppliers audit refusals to External Supply Quality upper management Issuance of Third-party audit report review Issue and maintain the List of Qualified External Supply Quality Auditors Monitor Supplier Quality related KPIs Issue and follow up the Suppliers and Service Providers Quality and Technical Agreements Coordinate, conduct and maintain the risk assessment of excipients used in medicinal products, as per EU Guideline for excipients (2015/C 95/02) Coordinate, conduct and maintain the external supplier risk assessment Participate in the main department’s processes including “Change Control”, “Deviation Investigation Reports”, “Corrective Preventive Actions”, “Risk Management Be responsible for development and review of departmental SOPs, TDRs, protocols and any other relevant controlled quality documents related to the assigned duties Actively participate in Customers’ Audits and Competent Authorities’ Inspection