Quality Assurance Compliance Officer (Sapes)
Pharmathen, Greece
Job Description
Pharmathenis one of the leading complex drug delivery and formulation developers and is amongthe top 50 pharmaceutical research companiesin 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 ofover 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 Ramp;D sector and employs over1,350 peoplefrom over24 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 Pharmaceuticalsoffers a great opportunity for career development and is seeking to attract aQuality Assurance Compliance Officer,to join ourQuality Assurance team atPharmathen’s Sapes premises.
As a Quality Assurance Compliance Officer, the ideal candidate will be responsible for ensuring compliance with GMP requirements and ISO standards.
Requirements
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
- Gather the approved information of the product and make appropriate communications with the customer, if required
- Be responsible for the validation of the facilities’ activities, such as Process Validations, Cleaning Validations, Utilities Validations etc.
- Prepare Product Quality Review Reports
- Participate in the preparation and review of Standard Operating Procedures, Technical Directives, and of the rest of controlled documents of the Quality System of the company
- 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, Reviews of rejections
- Participate in customers’ audits and authorities’ inspections; corresponding Capa Plan management
The ideal candidate should have:
- Educational background in Chemical Engineering, Chemistry, Biological, Pharmaceutical sciences or other relevant sector
- 1 - 3 years of experience in Quality Assurance within the Pharmaceutical Industry will be considered an asset
Job-Specific Skills:
- Fluency in English language (writing amp; 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.