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 Quality Assurance Specialist-LAI for the Corporate Quality Management department at our Sapes, Northern Greece premises.
As a Quality Assurance Specialist-LAI you will assure compliance to the GMP standards and ISO requirements.
More particularly:
What you will do:
- Ensure the compliance of the Quality Management Systemes Requirements according to FDA regulations, EU-GMP regulation and International Standard ISO 9001 and 14001
- Follow the rules of hygiene and control of health status as defined in the relevant Standard Operating Procedures
- Be responsible for the description of the codification system of the documents. Develop and execute all the necessary quality activities for the preparation of the proper descriptions on the codification system
- Communicate the appropriate information to all the involved departments in order the new codes to be issued and settled. Keep the needed records for the monitoring of the notifications and the flow of the process
- Implement the needed quality activities for the potential corrections on the codification system
- Support Regulatory Submission of Dossier
- Take part in preparation and authorship of the Quality Management departments SOPs,
- TDRs, and other controlled documents of the Quality System of the company
- Handle monitoring, archiving and notification of the main departments processes including
- “Corrective and Preventive Actions”, “Quality Risk Management” and “Deviations”
- Be responsible for quality records of the Quality System related to LAI facility
- Perform internal audits
- Perform training sessions on new or revised SOPs
- Maintain file of Protocols by subcontracted companies and maintain records on this
- Participate in all special occasions in regards to the Corporate Quality Management needs and authorizations
- Participate in media-fill simulation process in aseptic manufacturing area and relevant reporting
- Follow Quality system SOPs in day to day activity
- Perform and coordinate Investigation of Deviations/Complaints and contribute to root cause identification
- Identify CAPA actions, implements CAPA plans and monitors CAPA action implementation
- Comply necessary data for investigation conduction/performs shop floor visits for data compilation
Requirements
Minimum Qualifications
- BSc in life sciences, engineering, pharmacy or equivalent
Minimum Experience
- 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
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.
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Last updated on Jul 2, 2024