Quality Assurance Officer (temporary)

Accord Healthcare; Barcelona; Presencial; EUR 32.000 - 46.000; Jornada completa

Descripción de la vacante

Accord Healthcare in Barcelona is seeking a Quality Assurance Officer for a temporary role to ensure compliant QA practices for EU distribution. You will support the Spanish affiliate in maintaining QA processes and liaise with external partners and internal teams.

Responsibilities include managing the QA system, handling change controls, deviations, CAPA, and product recalls, while overseeing batch documentation and annual quality review.

Formación

• At least 2 years’ experience in the Quality Assurance department of a pharmaceutical company.
• Knowledge of QA principles, GMP/GDP requirements in the EEA.
• Knowledge of Spanish and European QA regulations.
• Experience in an international work environment.

Responsabilidades

• Manage and maintain an effective and compliant Quality Management System for Accord Healthcare SLU.
• Assist in QA policies and procedures.
• Handle local Change Control, Deviations and CAPA processes.
• Handle product market returns and liaise with wholesalers and distributors.
• Review and track Annual Product Quality Review.
• Collect and analyze quality data and support Management Review Process.
• Prepare batch documentation for Responsible Person batch release.
• Handle customer complaints and lead local investigations and CAPAs.
• Provide support to Marketing, Sales and Customer Service.

Conocimientos

Problem Solving

Drive for Results

Time Management

Peer Relationships

Descripción del empleo

We are looking for a Quality Assurance Officer (temporary role) to join our Accord Healthcare team in Barcelona.

• Carrying out quality assurance activities related with the distribution of pharmaceutical medicinal products in the European Union for which Spanish Affiliate (Accord Healthcare SLU) is the Marketing Authorisation Holder
• Building and maintaining good working relationships with external partners such as Wholesalers and Distributors, in addition to Accord Healthcare SLU customers.
• Providing support to internal stakeholders and to tasks related to the Global Quality Management System implementation at Spanish affiliate.

The Role

• Manage and maintain an effective and compliant Quality Management System for Accord Healthcare SLU.
• Assist in the quality assurance policies and procedures.
• Manage of local Change Control, Deviations and CAPA processes.
• Handle of product market returns, liaising with appropriate Wholesaler´s personnel to reject or return the product to the saleable stock.
• Review and track Annual Product Quality Review.
• Collect and compile statistical quality data, monitor and perform trend analysis to support Management Review Process.
• Preparation of batch documentation and associated quality assurance activities in support of Responsible Person batch release to market.
• Handle of customer complaints, co-ordinating local investigation to progress complaint closure, and any subsequent field corrective actions/ recalls.
• Provide support to internal stake holders, in particular to Marketing, Sales and Customer Service departments.
• Review of product packaging material in compliance with the product marketing authorization.
• Manage shortages notifications of Accord products and maintain smooth communication with the Health Authorities.

Core Competencies

• Problem Solving: Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn't stop at the first answers.
• Drive for Results: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results.
• Time Management: Uses his/her time effectively and efficiently; values time; concentrates his/her efforts on the more important priorities; gets more done in less time than others; can attend to a broader range of activities.
• Peer Relationships: Can quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.

The Person

• At least 2 years’ experience working in the Quality Assurance department of a pharmaceutical company.
• Knowledge of Quality Assurance principles, concepts and standards, as well as knowledge of pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements within the EEA.
• Knowledge of Spanish and European regulations on QA / regulatory affairs
• Good understanding of market dynamics and requirements in Spain.
• Experience from an international work environment.
• Ability to demonstrate high organization skills, and with good attention to details.
• Excellent team player with the ability to establish and maintain effective working team relationships