QA Operations Technician

Há 3 dias


Lisbon, Portugal Recipharm Tempo inteiro

Mission:

The QA Operations Technician is responsible for driving supplier and services management to ensure that they comply with the required quality standards (GMP, International, National, and internal company regulations).

Your key responsibilities:

Enforce the implementation of Quality Management System in projects with lower level of complexity, and support its overall implementation in more complex projects, assuring that production operations are clearly defined and implemented, and that each batch is produced and controlled in conformity with Good Manufacturing Practice. Work with Project Managers and Team Leaders, as applicable, in the context of less complex projects, to help define and approve production processes, final product specifications and documentation according to the Quality Management System, as well as final product analysis, making decisions on how to ensure conformity with the defined guidelines and Quality Agreements. Define corrective and preventive actions in projects with lower level of complexity, to address non-conformities and enforce guideline follow through, including discrepancies, reprocessing and rework procedures, and assist in this definition for projects with higher complexity. Ensure records are made, manually or through instruments during manufacture, all necessary controls are clearly defined and carried out for product and intermediaries, and that the remaining in process controls and validations are performed. Revise project and production operations reports and documentation to verify if the production process followed internal procedures and Good Manufacturing Practice, and forward conclusions to the Qualified Person. Analyze quality indicators and implement Quality Management Systems tools, interpreting its results and assessing the impact of eventual non-conformities for the project. Track and keep up to date with national and international legal and regulatory requirements and good pharmaceutical manufacturing practices, making sure all the relevant parties are informed, including the management team. Identify and leverage continuous development opportunities, reporting those to the Quality Assurance Manager and helping making decisions concerning actions to be taken, in order to contribute to GenIbet's quality system, processes and support activities' constant performance improvement. Guarantee independence from the manufacturing process at all times, ensuring that there is no conflict between quality assurance, regulatory and daily activities' responsibilities.

Profile

Academic education in pharmaceutical fields of study GMP Knowledge Minimum 2 year’s experience Fluent English (spoken and written) Organizational skills Strong communication skills

Skills and attributes for success 

Business mindset A strong work ethic Systematic knowledge and study of the most recent Global, Regional and local risk management policies and procedures Technical rigor and attention to detail Strong problem-solving skills Professional responsibility, confidentiality and integrity Efficient, innovative and team-oriented work environment Dedicated, innovative, resourceful and able to work under pressure Ability to manage multiple projects and stakeholders

If you are interested in this position, send your application to recursos.humanos@genibet.com



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