Elaborates, updates, submits for approval the Quality Assurance documents, respectively the quality system documentation, having as reference the GMP standards for medicines for human use, including medicines for clinical investigation, GDP standards, national legislation and regulations and international standards in force, as well as the company's standards, policies and procedures.Manages locally quality alerts, complaints regarding product quality or suspected product counterfeiting, including management of complaints on relevant platforms/ systems.Manages and participates in the risk identification process and risk assessment process of excipients.Performs GxP-specific training of GxP staff and manages training-specific documents.Performs specific operations for the Quality Assurance department in the SAP electronic system (eg Creating/ modifying material codes, blocking and unblocking materials, generating/ modifying BOM, initiating and closing change requests, periodically running the expired material blocking program) .Elaborates the documentation for the annual evaluation of the quality of medicinal products manufactured in Labormed Pharma (PQR).Actively participates in the Change Control process, including registration and monitoring in relevant platforms/ systems.Registers and participate, as appropriate, in the investigation of any deviation found regarding the products and/ or processes within the company, including registration in the relevant platforms/ systems.Participates in the elaboration of the CAPA plan, registers and monitors in the electronic system the status of the implementation of preventive and corrective actions and makes the necessary steps in order to implement the established actions.Performs periodically, according to the procedures in force, trend analyzes for complaints and proposes corrective and preventive measures to improve these processes.

Monitors and supports development and deployment of Project Plan, operational quality assurance processes and documentation (in cooperation with PM and PL)Monitors the respect of project management methodology, norms and customer standards (e. g. internal audits)Participates and assists in the preparation of meetings: KoM, contractual reviews, Project reviews etcMonitors the risk management process complianceSupports the definition of KPIReviews KPI and supports / monitors follow-up activities in case of non-conformitiesSupports and monitors root cause analyses as well as corrective and preventive actionsRe-visit error categories on a periodically basis with the team and ensure that error categories are yielding the appropriate root cause.Collaborate with QAMs at other sites and benchmark best practicesIdentify and assist in the implementation process of global continuous improvement projects.Reports to the Head of Quality

Ensure continuous compliance with ISO 14001 requirements;Identification of environmental aspects, setting environmental objectives and developing an environmental management program;Represents the company during external environmental audits;Ensure implementation of relevant environmental legislation at company level;Establishment and coordination of waste management activities;Elaboration of specific to waste management documents.

Monitoring and verification of plastic packaging materials processes;Continues compliance with ISO 9001 and 14001 requirements;Improvement, implementation and maintenance of the Quality and Environment Management System;Company representative during external audits;Training of new employees regarding ISO requirements, Company's policy, quality and environmental objectives, hygiene rules and specific job requirements;Identifying the training needs of staff involved in quality control and product packaging;Internal audits and follow-up;Elaboration of quality certificates;Implementation of corrective actions for all nonconformities;Permanent surveilance of customer satisfaction;Ensuring and tracing traceability;Responsble for measurement reports of new products;Participating in risk analysis;Identification of environmental aspects, setting environmental objectives and developing an environmental management program;Represents the company during external environmental audits;Ensure implementation of relevant environmental legislation at company level;Establishment and coordination of waste management activities;Elaboration of specific to waste management documents.