13 sep
|
Accord Healthcare
|
Cataluña
13 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
Providing support to internal stakeholders and to tasks related to the General Quality Management System implementation at Spanish affiliate.
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.
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.
is excellent at honest analysis; Time Management: Uses his/her time effectively and efficiently; 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
📌 Quality Officer (Cataluña)
🏢 Accord Healthcare
📍 Cataluña