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 Product Quality Life Cycle Officer to join our QA Operations team at Sapes, Northern Greece premises.

The Product Quality Life Cycle Officer is responsible for assuring compliance of all activities of the facility and warehouses with the EU cGMP requirements and ISO standards, as well as, customers’ demands. 

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
• 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 and product life cycle
• Evaluate of the facilities’ activities, such as Process Validations, Cleaning Validations, , and other activities related to product life cycle and prepares respective reports
• Prepare Protocols for Process Validation, cleaning Validation, etc. and ensure implementation and compliance
• Participate in shop floor validation activities and ensure compliance
• Evaluate the results for environmental monitoring and Utilities Validations as well as the corresponding overall reporting
• Assist in preparation or/and review of the production, packaging technical directives and Bill of Materials
• Prepare or/and review of Product Quality Review Reports
• Collect data for preparation of Product Quality Review Reports and perform statistical analysis
• 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 along Product Life cycle
• Assist in 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. and evaluates results
• Collect KPIs data of the facility and report them to Corporate quality management
• 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:

• Educational background in Chemical/Mechanical/Production Engineering, Pharmacy, Chemistry, Biological, or other relevant sector
• 1-3 years’ experience in Quality Management will be considered an asset

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.