Quality Assurance Compliance Officer
Pharmathen, Greece
Job Description
We are one of the leading complex drug delivery and formulation developers, using our key in-house technologies to support improved patient compliance. We service a broad partner network of over 250 customers in over 90 countries throughout Europe, North America, South America, Middle East, Asia, Australia and Southern Africa.
Our portfolio consists of over 100 products, and today we are working on one of the most extensive and advanced pipelines in Long Acting Injectables, Sustained Release formulations and Preservative Free Ophthalmics, produced in our in-house US-FDA and EU-approved facilities.
We proudly employ more than 1,200 people from over 22 different nationalities across 9 locations. We welcome the opportunity to expand our collaboration with existing partners as well as to establish new partnerships, while remaining committed to our vision to make a difference in people’s lives through our everyday activities and our products.
Due to continuous growth and expansion, Pharmathen Pharmaceuticals offers a great opportunity for career development and is seeking to recruit a Quality Assurance Compliance Officer to join our Quality Assurance teamat Pharmathen’s Pallini premises.
As a Quality Assurance Compliance Officer, the ideal candidate will be responsible for ensuring compliance with GMP requirements and ISO standards.More particularly:
What you will do:
- Ensure the compliance of the Quality Management System’s Requirements according to International Standard ISO 9001 and EU cGMPs
- Gathers the approved information of the product and makes appropriate communications with the customer, if required
- Responsible for the validation of the facilities’ activities, such as Process Validations, Cleaning Validations, Utilities Validations etc
- Prepares Product Quality Review Reports
- Participates 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
- Handles 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
- Participates in customers’ audits and authorities’ inspections; corresponding Capa Plan management
Requirements
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.