Quality Operations Senior Officer (Rodopi)

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 attract a Quality Operations Senior Officer to join our Quality Assurance team at our Sapes, Rodopi premises.

As a Quality Operations Senior Officer, the ideal candidate will be responsible for ensuring compliance with GMP requirements and ISO standards.

More particularly:

What you’ll do:

• Follow Company's Quality Policy and comply with current operational standards and legislative requirements
• Work in accordance with the requirements of the written Policies, Standard Operating Procedures, Technical Directives and Protocols of the company's Quality System, that are related to the duties of the described position
• Follow the rules of hygiene and control of health status as defined in the relevant Policies and Standard Operating Procedures
• Ensure the compliance of the Quality Management System’s Requirements according to International Standard ISO 9001 and EU cGMPs
• Communicate with the Regulatory Affairs Department regarding the approved information of the product
• Support Regulatory Submission of Dossier and management of Dossier Regulatory Compliance check
• Communicate with customer regarding any quality queries related with the activities of the facility
• Handle organization and monitoring of the facilities’ activities, such as Process Validations, Cleaning Validations, Aseptic Process Simulation, etc
• Evaluate and report the results for environmental monitoring and Utilities Validations
• Review the production, packaging technical directives and Bill of Materials
• Prepare and/or review of Product Quality Review Reports, trending reports and annual yields reports
• Take part in preparation, authorship and issuance of the the Site SOPs and TDRs as well as other controlled documents of the Quality System of the company
• Ensure the implementation of the annual training schedule of the personnel and organization of the scheduled and non scheduled training sessions
• Handle monitoring, archiving and notification of the main department’s processes including “Change Control”, “Corrective Preventive Actions”, “Risk Management”, “Deviation Investigation Reports, Complaints, OOS results, OOT results, Internal Audits, Data Integrity and QA Oversight, Escalation Management etc.
• Participate in multidisciplinary team for performing investigations
• Participate in customer audits and authorities’ inspections and corresponding Capa Plan management

Requirements

The ideal candidate should have:

• BSc in Chemistry, Biology, Pharmacy, Engineering or equivalent
• Experience within a manufacturing unit / laboratory / Quality unit operating under GMP / GLP / ISO or other regulatory standards
• 3 - 5 years of experience in Quality Assurance in Pharmaceutical Industry will be considered an asset.

Job-Specific Skills:

• Fluency 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.