- Overall operational QA support on UCB global vendor management, i.e. Contract Manufacturing Organizations (CMOs) for drug product, drug substance and intermediates;- QA review/approval of complaint investigation reports, major and critical deviations reports, out-of-specification (OOS)/ out-of-trend (OOT)/ out-of-expectation (OOE) results; - Investigations & root cause analyses related to deviations, complaints etc.;- Support on Change Control preparation and QA review;- Follow-up on annual product stability program and review/approval of stability protocols and reports;- QA support on process/packaging validation protocols and reports;- Review of master batch records;- Assessment of Annual Product Quality Reviews (APQR);- Support on periodic operational vendors’ risk assessment;- Analysis and maintenance of Key Performance Indicators (KPIs);- Review and update of quality agreements with vendors;- Support on customer audits and regulatory inspections preparation;- Participation in for-cause audits as Subject Matter Expert (SME);- Back-up activities of the Vendor Quality Lead.

- QA management of global commercial partners ensuring compliance with GMP/GDP requirements and UCB global Quality Management System (QMS);- Creation, review, approval and periodic update of quality agreements;- Management of product quality complaints, change control requests/notifications, deviations, recalls and returns;- Participation as QA representative to the recurrent meetings with commercial partners (regular follow-ups; issues resolution, etc.)- Execution of periodical risk assessments;- Support on product launches and general regulatory activities (submissions, renewals, etc.);- Extensive involvement (QA representative) in product portfolio divestments;- Audit preparation and back-office support;Project-related activities: > Development of standard operating procedures (and associated instructions) to be used as basis of global commercial partners’ Quality management; > Participation in cross-functional projects within UCB global external network governance; > Support on projects linked to the revamping of UCB global QMS.

• Cooperation on the QA management of global alliance partnerships (e.g. in-licensing, out-licensing, co-development, distributors, etc.)- Creation and maintenance of database of the different categories of global commercial partners;- Support on the delineation of Quality standards for day-to-day management of global commercial partners;• Support on management of product quality complaints, change controls, deviations and other QA requests;

- Evaluation and validation of medical prescriptions;- Biochemical and physiological parameters monitoring;- Dispensing medication, pharmaceutical counselling and follow-up;- Preparation of compounding drugs;- Order and inventory management and other administrative activities.

- Inventory management and dispensing of medication;- Pharmacovigilance operations on hospital drugs administration;- Outpatients visiting;- Preparation and validation of procedures in the cytotoxic preparations unit;- Preparation and validation of non-sterile dosage forms;- Application and follow-up of clinical trials procedures.

- Evaluation and validation of medical prescriptions;- Dispensing medication;- Preparation of compounding drugs;- Orders, stock management, storage procedures and contact with suppliers.