Third Party Quality Operations 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 1,300 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 Third Party Quality Operations Officer for the Corporate Quality department in our Pallini premises.
As a Third Party Quality Operations Officer will be responsible to assure compliance to the GMP standards and ISO requirements by maintaining an accurate and up to date QA database.
More particularly:
Requirements
What you will do:
- Ensure GMP compliance of products tested at a contract facility
- Monitor contractor compliance via GxP documentation review and through the established communication channels
- Maintain Pharmathen’s Management Quality System as applicable by opening, reviewing, and / or approving relevant records (e.g. deviations, CAPAs, Change Controls), ensuring compliance with applicable corporate and regulatory standards
- Interface with other local and corporate departments regarding registration submissions requirements and replies to deficiency letters related to products manufactured in contract manufacturers
- Assure ongoing compliance with quality and industry regulatory requirements
- Follow Company's Quality Policy and complies 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
The ideal candidate should have:
- BSc Degree in chemistry, pharmacy or relevant field
- At least 2 years of experience in Quality Management
Job-Specific Skills:
- Excellent communication 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.