Quality Assurance Technician Lisboa

Quality Assurance Technician
Lisboa
Lisboa, Lisboa, Portugal

Tecnimede Group is a Portuguese multinational company, with more than 40 years of history in the life cycle of the drug product for human use — development, production, promotion and marketing – with the mission to improve and preserve the human life and the human health. Exporting to more than 100 countries worldwide, it is present in 6 countries (Portugal, Spain, Italy, Morocco, Colombia and Brazil) with a strong focus in expanding internationally and building strategic partnerships.

To strengthen our core team in Caixaria - Torres Vedras we are looking for a Quality Assurance Technician to join our company.

You will be responsible for:

Authors and reviews SOPs and policies. Create and establish process and procedures to ensure compliance and adherence to regulations and c
GMP operations.

Identifies, classifies and reports deviations, as appropriate and typically works on more complex minor and/or major deviations.

Oversees execution of remediation/CAPA activities required to continue production, move a process to the next milestone. Works closely with others to determine root cause and potential preventive/ corrective actions. Ensure timely closure of investigations.

Responsible for providing quality oversight to the change management system for change controls related to cell bank and cell vaccine manufacturing. This includes providing plan creation oversight, verifying that changes adhere to SOPs and regulatory compliance.

Ensures all specifications are met and that applicable requirements are completed and acceptable.

Participate in quality oversight of testing,
- time observation of activities.

Work closely with others to recognize opportunities for improvement and drive change through the use of Quality Systems.

Participate in internal audits for compliance with SOPs, GMPs and regulations.

Perform other duties as assigned.

We are looking to recruit:

Proven work experience as a Quality Assurance technician or similar role( 3 years minimum;

Working knowledge of tools, methods, and concepts of quality assurance;

Experience applying GMP and data integrity requirements in a QC setting;

Good communication skills, both verbal and written;

Strong level of analysis skills to evaluate and interpret data to arrive at logical and
- minded conclusions.

Strong attention to detail;

Growth mindset, optimist that believes in continuous improvement;

A team player with high sense of responsibility and perseverance;

"In accordance with the provisions of the GDPR and other legislation in force on personal data protection, the contracting company guarantees that the processing of your personal data is lawful, fair, transparent and limited to the purposes for which your data was collected. "