Ensure BIALs’ new products quality throughout its manufacturing chain and coordinate Quality matters in the Technology Transfer projects of new medicines and in the launch of new products in line with the orientation and goals set by the company.
Control Quality throughout the manufacturing chain of BIAL products;
Support, under Quality, the projects of Technology Transfer (manufacture and control) of new products;
Work in partnership with subcontractors to promote continuous improvement and ensure the quality of new products;
Manage quality issues within the supply chain and third parties;
Prepare and periodically review the Quality Agreements established with third party subcontractors, licensees, licensors, distributors and manufacturers of API and finished product;
Ensure the preparation/coordination of Product Quality Review (PQR) reports for products manufactured (BIAL as well as products manufactured in CMO);
Review/executed Master Batch Records Manufacturing Dossiers (products manufactured in Bial and products manufactured by third parties) and IMP (Investigational Medicinal Products);
Approve BIAL's printed materials in compliance with the regulatory implementation dates.
Degree in Pharmaceutical Sciences or Life Sciences;
5 years experience in Pharmaceutical Industry as internal and external quality control interface (preferred);
Previous experience in drug technology transfer projects;