RD Lab Documentation 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 anRamp;D Lab Documentation Officerto join ourOrganic Synthesis APIs at Pharmathen’sPallinipremises.
As anRamp;D Lab Documentation Officeryou will be responsible for the technical and documental support based on internal SOP’s in the laboratory activities of API Ramp;D.
More particularly:
What you’ll do:
- Adhere to safety and housekeeping requirements
- Prepare / review SOPs, TDRs and other documents / report related to laboratory equipment and projects undertaken (e.g. stability studies, etc) in collaboration with the personnel of the relevant departments.
- Prepare Certificates of Analysis (CoAs)
- Ensure the right keeping of quality records (e.g. environmental monitoring, etc)
- Maintain up-to-date the SAP system for laboratory equipment and the respective quality system records
- Coordinate the equipment calibration / qualification (planning, monitoring, review, record keeping, etc)
- Coordinate the dispatch and delivery of samples and standards with external and internal parties
- Initiate change plans and/or is involved in change plan tasks
- Be involved in the quality management system procedures related to deviations, corrective preventive actions (CAPAs), etc.
- Be key user in eQMS related modules (e.g. documentation, etc)
Requirements
The ideal candidate should have:
- BSc in Life Sciences or in Medical Laboratories
- At least 5 years of practical knowledge gained through experience accompanied by a technical or vocational training
- At least 2 years of experience in the Pharmaceutical Industry or equivalent experience
Job-Specific Skills:
- Excellent communication in English language (writing amp; speaking)
- Troubleshooting skills
- Computer literacy
- Excellent laboratory / analytical knowledge on lab procedure and knowledge on maintaining laboratory equipment
- Maintain tracking database of reference standards and reagents
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.