Quality Operations Specialist 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 Specialist to join our Quality Operations team at our Sapes premises.

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

More particularly:

What you’ll do:

• Ensure the compliance of the Quality Management Systems Requirements according to FDA regulations, EU-GMP regulation and International Standard ISO 9001 and 14001
• Take part in preparation and authorship of the Quality Management departments SOPs, TDRs, and other controlled documents of the Quality System of the company
• Provide real-time quality oversight during aseptic manufacturing, including formulation, filling, visual inspection, and packaging of sterile injectable products
• Review and approve batch manufacturing records (BMRs), logbooks, and controlled documentation related to sterile operations
• Act as the primary QA contact for customer-related quality matters, including deviations, documentation requests, and quality-related queries
• Coordinate and lead interdepartmental quality improvement initiatives, involving departments such as Production, Microbiology, Engineering, and Supply Chain
• Manage quality-related projects at site or product level (e.g., CAPA implementation, contamination control, trending, qualification)
• Participate in deviation investigation, root cause analysis, and escalation processes, ensuring timely and compliant resolution
• Oversee and support activities related to environmental monitoring (EM), personnel monitoring (PM), and aseptic process simulations (media fills)
• Monitor and assess gowning compliance, operator behavior, and aseptic techniques in classified areas
• Support the Contamination Control Strategy (CCS) implementation in alignment with EU Annex 1
• Contribute to regulatory inspections, internal audits, and customer audits as QA representative
• Participate in training, coaching, and qualification of new employees working in aseptic operations

Requirements

Requirements

• BSc/MSc in Pharmacy, Chemistry, Biology, Chemical Engineering, or a related field
• 5-7 years’ experience in Quality Management or relevant department

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
• Broad knowledge of pharmaceutical quality system
• Extensive knowledge of European GMPs, as well as global demands, in order to be able to ensure compliance with national, European, and global standards
• Effective problem solver and strong initiative and creativity skills
• Familiarity with QMS tools such as Electronic Quality Management System

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