Qualimetrix S.A. is a third-party Contract Research Organization, established in 2013, that provides analytical services to pharmaceutical industry.
Qualimetrix S.A. is involved in the development of the Quality part of pharmaceutical products (module 3) as well as in R&D, QC activities and QP services.
In the frame of its activities Qualimetrix S.A. is recruiting a Resources and Planning Officer for the Quality Control Department based in company's laboratory in Athens, Greece.
- Holds responsibility for the design of the validation studies to be undertaken by the QC Department by taking into consideration the applicable guidelines, authorities’ requirements etc. and if necessary, by performing literature review. Performs timely the review of the client’s requests (for the submission of the laboratory’s proposal to the client).
- Holds responsibility for the monitoring of the essential guidelines related to the laboratory’s validation activities (e.g. ICH Q2 etc.) and timely notifies for any changes and/or new requirements.
- Writes and/or reviews validation protocols and reports for the validation activities of the department (e.g. method validation, cleaning validation etc.). Also, participates – by writing and/or reviewing the respective protocols and reports – in the “technology – transfer" activities of the department (i.e. Analytical Method Transfer and/or Verification).
- Holds responsibility for the preparation of the validation studies undertaken by the laboratory department, including ordering of consumables, ensuring that all documentation needed has been sent by the client etc. after confirmation of client’s approval by the Business Department etc.
- Holds responsibility for the execution of the validation studies undertaken by the laboratory department, including: a. the design and monitoring of the “feasibility" experiments conducted prior to the study, b. the review of the study conducted (raw data, records in logbooks, audit trails etc.), c. the identification, reporting and investigation of any deviations and/or other analytical issues and d. the archiving of the study (physical & electronic).
- Holds responsibility for the smooth operation of the QC department and the team he/she is responsible for, by preparing and/or reviewing quality control procedures, training and providing technical assistance to the laboratory officers, overviewing/coordinating the analytical activities etc.
- Identifies and reports to the QC Manager the needs of the department regarding additional/new equipment and contributes in its selection (URS compilation etc.) and purchase.
- Holds responsibility for the tidiness the cleanliness and the laboratory area.
- Provides assistance to the QC Manager.
- Holds responsibility for the communication with the client (e.g. samples’ receipt, delivery of protocols and reports, technical issues related to the studies conducted etc.).
Work experience requirements
Two (2) or more years’ experience with analytical method validation under GMP environment.
- BSc in Chemistry or Pharmacy
- Excellent knowledge of the English language (CEFR Level C2)
- Excellent knowledge of Microsoft Office applications
- MSc in Chemistry/Pharmaceutical Analysis
-Friendly corporate culture
-High level training on GMP and related fields
-Scientific working environment with strong motivating character
Keywords: Chemist, Pharmacist, Χημικός, Φαρμακοποιός