RD Quality Protocols Senior Officer
Pharmathen, Greece
Job Description
Pharmathenis 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’sportfolio 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.
Pharmathenis 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 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 Pharmaceuticalsoffers a great opportunity for career development and is seeking to attract an Ramp;D Quality Protocols Senior Officer to join ourAnalytical Development team at Pharmathen’sMetamorfosipremises.
As aRamp;D Quality Protocols Senior Officer you will Get involved in the preparation of Ramp;D quality protocols amp; review for assigned projects in accordance to EU /FDA standards and corporate requirements.
More particularly:
What you’ll do:
- Keep abreast of international legislation, guidelines and customer practices
- Prepare high quality technical documents related to Ramp;D department (analytical procedures, specification, validation, photostability, forced degradation and other protocols)
- Prepare relative dossier sections and monitors timelines to be delivered to CMC
- Review the corresponding analytical raw data, calculations and reports
- Prepare/ review SOPs related to analysis and laboratory instrumentation
- Handle the internal procedures of change plan, deviations, OOS, risk assessment for the analytical Development group.
- Communicate directly with the Analytica Development Team, QA dpt, CMC team for each project
- Upgrade documentation as per EU and FDA requirements (regulation, pharmacopoeias)
- Assume other activities and responsibilities as directed
Requirements
The ideal candidate should have:
- Minimum of a Bachelor’s Degree in a scientific discipline (preferably Chemical Sciences, or Biochemistry)
- At least 5 years relevant experience in the pharmaceutical area
- Experience in analytical techniques (HPLC,GC,etc.)
Job-Specific Skills:
- Excellent communication in English language (writing amp; speaking)
- Computer literacy
- Troubleshooting skills
- Time management
- Ability to work on multiple projects and meet timelines
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.