Third Party Quality Operations Senior Officer

Pharmathen is one of the leading complex drug delivery and formulation developers and is among the top 50 pharmaceutical research companies in Europe. Driven by innovation, the company specializes in one of the most modern and technologically innovative sectors, developing Long Acting Injectables (LAI), Sustained Release formulations and Preservative Free Ophthalmics.

Pharmathen’s portfolio consists of over 100 products , produced at its facility in Sapes, Rodopi, approved by the US Food and Drug Administration (FDA), and at its modernized production unit in Pallini, Attica.

Pharmathen is one of the largest private investors in research and development in Greece, with steady investments of €35 million annually in the R&D sector and employs over 1,350 people from over 24 different nationalities . The company's enduring success is attributed to the passion for creativity, the ethics, and dedication of its people, who share 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 Third Party Quality Operations Senior Officer for the Corporate Quality Management department in our Marousi premises .

As a Third Party Quality Operations Senior Officer , the ideal candidate will assure compliance to the GMP standards and ISO requirements by maintaining an accurate and up to date QA database.

More particularly:

Requirements

What you will do:

• Ensure GMP compliance of products produced and tested at a contract facility
• Perform Quality review of analytical and manufacturing documentation including method validation protocols/reports, in-process data/batch release data, certificate of analysis, stability protocols/reports, manufacturing instructions, process validation protocols/ reports
• Oversight of the external activities associated with manufacturing, disposition, and distribution of drug products
• Participate in root cause analysis and develop project plans and/or corrective action that may impact multiple functions (including CMOs)
• Monitor contractor compliance via GxP documentation review and through the established communication channels
• Maintain Pharmathen’s Management Quality System as applicable by opening, reviewing, and / or approving relevant records (e.g. deviations, CAPAs, Change Controls), ensuring compliance with applicable corporate and regulatory standards
• Interface with other local and corporate departments regarding registration submissions requirements and reply to deficiency letters related to products manufactured in contract manufacturers
• Assure ongoing compliance with quality and industry regulatory requirements

The ideal candidate should have:

• BSc Degree in Chemistry, Pharmacy or equivalent field – MSc is desired
• At least 2 years’ experience in Quality Management

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

Benefits

What 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.