Quality Operations Officer - OSD/LAI (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 Officer to join our Quality Operations team at Pharmathen’s Sapes premises.

As a Quality Operations Officer, you will ensure compliance with the EU cGMPs requirements and ISO standards.

More particularly:

What you’ll do:

• Ensure the compliance of the Quality Management System’s Requirements according to International Standard ISO 9001 and EU cGMPs
• Manage personnel’s training records
• Gather the approved information of the product in collaboration with the Regulatory Affairs Department.
• Perform validation of the facilities’ activities, such as Process Validations, Cleaning Validations, Utilities Validations etc
• Review the Product Profile Reports based on the product code and corresponding approval of Bill of materials
• Prepare Product Quality Review Reports
• Monitor the Pest Control System (monitor process, keep archive, communicate with the supplier for emergency incidents, audit’s observations, new requirements after changes in use of areas.
• Review the Dossier Regulatory Compliance
• Participate in Quality Assurance Department’s SOPs and TDRs' preparation
• Monitor and maintain department’s processes including “Change Control”, “Corrective Preventive Actions”, “Risk Management”, “Deviation Investigation Reports, Complaints, OOS results, OOA results, Internal Audits, Reviews of rejections
• Participate in customer audits and authorities’ inspections and corresponding Capa Plan management

Requirements

The ideal candidate should have:

• Educational background in Chemical Engineering, Chemistry, Biological, Pharmaceutical sciences or other relevant sector

Minimum Experience

• 1-3 years’ experience in a pharmaceutical Quality Management department

Job-Specific Skills

• Excellent communication in English language (writing & speaking)
• Computer literacy
• Exceptional communication skills, strong project management skills
• Ability to prioritize tasks and meet deadlines

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