Kortrijk, Flemish Region, Belgium
Various roles related to quality in pharmaceutical and healthcare industry with +25 years of experiences (QC, QA, QP, QPPV, RP) in EU GMP, EU GDP, ISO13485 and ICH guidelines. Specialist in a wide range of quality management systems for pharmaceuticals and healthcare products dealing with sourcing, mixing, blending, filing and packing operations, quality control, quality assurance, batch release, batch certification, storage, transport & distribution, auditing, risk management, training, outsourced activities, supply chain, vendor management, qualification & validation, manufacturing, testing, process & temperature mapping, CSV, complaint handling, CAPA, OOS, change control, pharmaceutical design, PQR, FMD, quality objectives, quality culture, ALCOA+ and DI, CI, KPI, ... Data governance including data integrity, data security and ALCOA++. Focused on quality maturity and process excellence through continuous improvement. FMEA risk management as a tool to facilitate business. Prevent from quality issues via training, information sharing and feedback to personnel. Registered Qualified Person (n° 1621) in line with EU GMP. Responsible for quality management systems compliant to EU GDP, ISO13485:2016 (medical devices) and HACCP (food supplements). Experienced in commercial medicines and IMPs for use in clinical trials. Direct contact with affiliates, customers, vendors, authorities, notified bodies and other key stakeholders. Member of the Management team. Mentor of +10 trainees Master of Industrial Pharmacy (to become a registerd Qualified Person). Lector at Syntra Kortrijk/Roeselare (+10 years, Pharmacology).
Qualified Person for batch certification of medicinal dosage forms used in clinical trials, packaging and labelling operations in cleanroom environment and import within EEA. Responsible Person for sourcing, storage and distribution of (un)licensed medicinal products and medical devices. Responsible for the quality management system in compliance with cGMP and GDP. Creating a mature quality culture to foster process excellence. Quality as the basis for compliant operations and process excellence. Pragmatic approach without compromises to quality and compliance. Full responsibility for the Quality Management System. Direct contact with authorities and key stakeholders.
Qualified Person for batch release and batch certification of non sterile medicinal dosage forms (mainly liquids and semi solids) and authorized raw materials. Responsible for the quality management system related to medicines and health care products in compliance with cGMP, GDP, HACCP and ISO13485. Direct contact with authorities, customers, suppliers and stakeholders. Member of the management team. Direct report to Managing Director.
Medgenix Benelux NV - After integration of the PhV quality management system within the EU company structure, acting as a back-up Local Contact Person (LCP) for pharmacovigilance system for pharmaceutical products on behalf of Medgenix Benelux. Responsible for Quality Management System compliant to EU GVP. Reporting directly to EU QPPV.
Medgenix Benelux NV - Qualified Person for batch release and batch certification of non sterile medicinal dosage forms (mainly liquids and semi solids). Responsible for the quality management system related to medicines and health care products in compliance with EU cGMP, GDP, HACCP and ISO13485 quality standards. Direct contact with authorities, customers, suppliers and stakeholders. Directly involved in a wide range of quality topics in the organization within EU. Medgenix Benelux NV, located in Wevelgem, is a division of Perrigo. Member of the Leadership Council. Reporting directly to VP Quality & Operations CHCI (Perrigo).
Medgenix Benelux NV - Responsible pharmacist for the pharmacovigilance system for medicinal dosage forms of Medgenix Benelux. Contact person for authorities, customers and stakeholders.
Qualified Person for batch release of raw materials and antiseptic solutions for pharmaceutical use according EU GMP and ISO9001 quality systems. Responsible for EU GMP compliance and contact person for stakeholders, authorities and customers. Quality control of raw materials according Ph. Eur. and USP/NF. Managing the QC and QA department from operational and quality perspective. Member of the management team. Contact with national Competent Authorities.
Traineeship for 6 months to become a registered QP. Full service pharmaceutical manufacturing site: from starting material until finished product, incl. dispensing, blending, filling, packing and (steam) sterilisation. Mentor: Ind. Pharm. K. De Turck