Quality Assurance Technician - Food

Empresa Confidencial; Madrid; Presencial; EUR 30.000 - 40.000; Jornada completa

Descripción de la vacante

A leading pharmaceutical company in Valencia is seeking a Quality Assurance Technician to oversee compliance with Good Manufacturing Practices and manage various quality-related processes. Candidates should have a Bachelor's Degree in Sciences, quality assurance experience, and proficiency in both English and Spanish. This role involves collaboration on audits and documentation management, with occasional travel required.

Formación

• High level of English and Spanish.
• Willing to travel occasionally.
• Good working under pressure and good organizational skills.

Responsabilidades

• Ensure quality of processes and compliance with Good Manufacturing Practices.
• Review specifications and approve master batch records.
• Create and maintain HACCP documentation.
• Coordinate the Quality System and manage supplier documentation.
• Manage CAPA related to quality audits and complaints.

Conocimientos

Quality Assurance experience

SAP Management

Proactivity

Good communication skills

Problem-solving

Educación

Bachelor Degree in Sciences

Herramientas

MS Office

Descripción del empleo

Position

Quality Assurance Technician

Location

Valencia

Experience

+ 2 years

Global Responsibility

Ensure the quality of processes and take the necessary measures to ensure that products manufactured meet the Good Manufacturing Practices. Investigate deviations, complaints and OOS in order to propose corrective actions and improvements. Research and ensure corrective and preventive as a result of claims, customer audits. Ensure continuous improvement and maintenance of quality of equipment, systems and processes. Comply with the guidelines defined in the Quality Policy, Objectives of the company and with regulations and quality standards of organisms

Specific Responsibilities

Review specifications of bulk biopharmaceutical products.

Review and approve all master batch records and oversee computer system validation (e.g., SAP) to enable manufacturing processes.

Create and maintain Hazard Analysis and Critical Control Point (HACCP) documentation, adapted to pharma processes and products.

Collaborate as needed to ensure all client requirements and requests related to pharmaceutical products are addressed.

Coordinate the Quality System and serve as the main customer contact for pharma products.

Develop procedures and analytical specifications for bulk biopharmaceutical products.

Review documentation for raw materials, bulk, and finished biopharmaceutical products.

Manage Change Control processes for pharma products.

Manage complaints related to pharma products.

Manage deviations related to pharma products.

Oversee supplier management: approve and evaluate suppliers, and review and approve all supplier documentation relevant to pharma.

Collaborate in the performance of audits for contract manufacturing organizations (CMOs) in the pharma sector.

Collaborate in the performance of supplier quality audits specific to pharma.

Participate as a member of the shelf inspections audit team for biopharmaceutical products.

Collaborate in the management of Customer Quality Audits performed on site for pharma products.

Manage CAPA (Corrective and Preventive Actions) resulting from Customer Quality Audits, Complaints, Deviations, and OOS (Out of Specification) findings in the pharma context.

Competencies / Career Level

Innovation, customer orientation, communication, teamwork, adaptability / flexibility, productivity, Self-development, sense of urgency, Initiative.

Requirements and personal skills

Education:

Bachelor Degree in Sciences.

Languages:

High level of English and Spanish.

Experience (years / area):

Specific Knowledge:

Quality Assurance experience. SAP Management, MS Office system.

Travels:

Willing to travel occasionally.

Personal skills:

Good communication skills, proactivity, good working under pressure, problem-solving, good organizational skills and persistent.