19 sep
|
Accord Healthcare
|
Cataluña
19 sep
Accord Healthcare
Cataluña
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 General 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 #J-18808-Ljbffr
📌 Quality Assurance Officer (temporary) (Cataluña)
🏢 Accord Healthcare
📍 Cataluña