Pds Ad&gmp Documentation

PURPOSE OF THE POSITION / RESPONSIBILITY:
He is responsible for the assigned projects, He collaborates with all the functions within the company in the implementation of analytical projects respecting the company quality standards. 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), he supports investigations within departmental deviations and the management of OOS, OOT and laboratory investigations. It supports and coordinates the other functions of the QC PDS Documentation group.It supports the management of department audits. Manages and supports the opening of change controls within its competence. Collaboratewith other functions within the PDS department, especially with the PDS QC Team Leaders and the PDS QO department in order to ensure the smooth continuation of projects and compliance with the defined timelines. 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. Collaborates for the compilation, aggregation and approval of analysis reports relating to the checks carried out in compliance with company procedures and standards. Collaborate in 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.RELATIONSHIPS:
INTERIORS Production departments QA Regulatory Logistics TT / BusinessEXTERIOR 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