22 feb
Al Solutions
Estado de México
My client is a CDMO based in Barcelona, dedicated to developing and producing biopharmaceutical products, including new biological entities and biosimilars.
With a knowledge-driven approach, the company leverages cutting-edge technological platforms and works closely with its clients to deliver innovative solutions.
As part of its growth strategy, the organization is establishing a new GMP manufacturing facility equipped with state-of-the-art technology to support all phases of the production process.
Ideal Candidate The company is seeking a highly capable Quality Assurance Specialist to play a critical role in its operations.
The ideal candidate will have:
A bachelor's degree in pharmacy with at least 5 years of experience in GMP Quality Assurance roles.
Advanced knowledge in managing Quality Management Systems (QMS), including deviations, CAPA, change controls, audits, and supplier qualification.
Experience in the qualification of facilities, utilities, and equipment.
Expertise in batch release processes, with the ability to act as a QP deputy in compliance with Real Decreto 824/2010.
Strong problem-solving and decision-making abilities.
Excellent communication skills in both Spanish and English, with a team-oriented approach and solid analytical and organisational skills.
Role and Responsibilities The Quality Assurance Specialist will be responsible for: Supporting the establishment and maintenance of a comprehensive Quality Management System (QMS), including the creation and approval of SOPs for GMP manufacturing activities.
Designing and managing the Documentation Management System and coordinating related training programmes.
Overseeing the qualification of facilities, utilities, and equipment by approving protocols and reports, and managing associated change controls.
Leading the supplier qualification programme, including the approval of new suppliers and ongoing monitoring of supplier performance.
Reviewing Technical Agreements with suppliers and clients.
Reviewing batch documentation to support release activities.
Benefits and Opportunities This position offers: A unique opportunity for professional development by contributing to the creation of a Quality Management System from the ground up, while supporting GMP activities for a new manufacturing facility.
The chance to work on diverse biological products and gain comprehensive insights into the biopharmaceutical lifecycle.
A flexible work schedule adapted to process demands.
This is an exceptional opportunity for an experienced Quality Assurance professional to join a forward-thinking organisation at the forefront of biopharmaceutical development.
#J-18808-Ljbffr
Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.