Qc Pds Stability Support Technician Bardi

Qc Pds Stability Support Technician
Bardi
Emilia Romagna, Bardi

PURPOSE OF THE POSITION / RESPONSIBILITY:

Based on the information received from the Team Leader / Department Supervisor, it carries out the tasks and activities listed below for which it has been enabled by the appropriate training, in compliance with company and departmental SOPs and current safety regulations. SPECIFIC TASKS / PRIMARY ACTIVITIES:

To ensure, in support of the Team Leaders, the coordination of the stability studies and sampling necessary for each individual project of the QC PDS department in compliance with company quality standards and as agreed with customers Prepare the samples inside the climatic chambers of the site and / or interface with the qualified laboratories for their storage Monitor the deadlines for the stability studies and make sure that the stability time points are respected Prepare protocols and stability reports, interim reports with related trends Take care of the management ofstability studies both in manual mode and with the LIMS system Manage timely and punctual communication with customers and with other company functions, in relation to the activities of competence Implement the activities of competence, through the correct planning of daily activities, the control of the progress of the activities, in compliance with the priorities defined by the Manager and the company quality standards Ensure the correct management of the relevant analytical documentation, from receipt, to control, archiving and traceability, whether of internal or external origin, according to current procedures, company quality standards and analytical protocols and / or reports analytical Ensuring the issuance, verification and transfer of analysis reports relating to the controls carried out, through the coordination and control of the collection of analysis data, in compliance with company procedures and standards Contribute 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. RELATIONSHIPS:

INTERNAL Production departments QA Regulatory Logistics TT / BusinessEXTERNAL Clients External laboratoriesREQUIREMENTS AND QUALIFICATIONS:

ESSENTIALSStudies / Diploma / Training courses:

Bachelor's degree, higher chemistry diploma or proven experienceTechnical and IT 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 systemsProfessional experiences:

In the laboratory of analysis or laboratory of pharmaceutical technologyLanguages:

EnglishPersonality traits:

Flexibility Good organization and planning skills Listening and communication skills Ability to work in a team