Quality Assurance Technician

In a few words

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