Villers-le-Bouillet, Walloon Region, Belgium
I am working in the QA Release department from GSK Belgium. The QA Release is responsible among other to the submission of batches to national control laboratory, release and certification of all vaccine produce in Belgium but also produce at other GSK sites like Saint Amand or Marietta. One part of my job is QP delegate for DTPA, Hepatitis and Shingrix vaccines. In this role, I am responsible to batches certification, repack approval and the management of various product issues (for example deviation and change control). The other part of my job is coordinator QA. The objective of this role is to maintain and improve the quality system of the department to respect GSK policy and consistently improve our activities. I am responsible (SME) to several QA release activities (for example release under quarantine or the conformity check to regulatory dossier before release/certification). These responsibilities include staff training, SOP writing and update and processes improvement. I am doing project management (for example paperless project) and risk management. I also manage CAPA, self-inspection, change control task and deviation initiation and root cause analysis. Finally, I am managing all EHS aspect for QA release (sensitization, accident, dangerous situation, training,…)
Mithra CDMO is a contract development manufacturing organisation speciliazed in: - long acting medecine (sterile and non-sterile). - formulation and filling of sterile products. Operational QA team is responsible for all QA activities of the production and CMC departments but also QA activities linked to introduction of new products. My main responsabilities are: ⁃ manage a team of 3 QA experts and 3 QA technicians. ⁃ Review of quality events (deviation, change control, OOS, complaint and CAPA). ⁃ Review strategy and documentation linked to manufacturing and validation activities. ⁃ Review of EM documentation as risk analysis, trend analysis,… ⁃ Fronter for inspection and customer audit ⁃ QA oversight including good aseptic pratices. ⁃ Process improvement ⁃ Insure compliance to quality system and GMP. ⁃ Quality process training ⁃ QA contact for customer I have also lead the gap analysis and implementation of the GMP new annex 1 at mithra CDMO. Finally, I am also the QP back-up.
My job of “Specialist QA and QP delegate” is still for the QA release department and I keep all the majority of my former responsibilities and activities. The major differences are: 1. The management of a team of 11 people. The team management role includes: • To be the single point of contact for all complaint from internal and external customer. • Team KPI follow up. • Staff evaluation. • Work assignment 2. More responsabilities in term of project management and process improvement. The current main objectives of the departmnent are to automate non-humain added value activities and robust process compliance.