You will join the Analytical Development Team Leader in newly-built Pharmaceutical Development department and will perform required analysis to ensure that clients' requests are met according to SOP, GMP and GLP.
Supporting the Analytical Development Supervisor in multiple task, you will specifically be assigned the following activities:
PURPOSE OF THE POSITION / RESPONSIBILITY:
- Responsible for the assigned projects, he is responsible for the regulatory specifications related to QC PDS laboratory in such a way as to ensure the successful continuation of the projects within the PDS.
- Responsible for the regulatory specifications for APIs, Excipients and DP (release and stability tests).
- Collaborate with Clients, QC PDS and Regulatory Department in order to issue the correct specification for PDS projects, respecting the ICH and Pharmacopoeia.
- Ensures appropriate communication with customers in relation to the documentary activities of its competence, constantly participating in project calls and internal meetings.
As SME (Subject Matter Expert) for regulatory specifications he supports the projects and collaborates with the other functions of the PDS Departments (QC PDS; Project Management and Scientist).
- Manages and supports the opening of change controls within its competence.
- Plans and coordinates the regulatory documentary activities for the assigned projects in line with the related project plans aiming at OE / RFT / OTD.
- Contributes to updating the procedures relating to the area of competence, by drafting and reviewing them as needed, in compliance with current regulations, laws and GMP standards.
- Ensures the achievement of the company targets of On Time Delivery and Right First Time on the project activities of its competence.
It ensures the commitment to continuous improvement and therefore collaborates in the maintenance of LEAN processes
**Studies / Diploma / Training courses**:
- Bachelor's degree, higher chemistry diploma or proven experience
**Technical knowledge**:
- GMP standards applied to Quality Control laboratories, with particular reference to stability studies
- Knowledge of laboratory concepts and computer programs
- Knowledge of data management and evaluation systems
**Professional experiences**:
- In the laboratory of analysis or laboratory of pharmaceutical technology
Languages:
- English
- Italian