Quality Management in Sterile Manufacturing

Experienced consultant and director with over 25 years of expertise in the pharmaceutical industry, focusing on GMP (Good Manufacturing Practice) and quality management systems. Wilma Meijs has been the owner of Wilma Meijs Farmaceutisch Advies BV since 2011, where she provides consultancy services in GxP for pharmaceutical companies.

Expertise and Services:

• Project Leadership in validation of processes and equipment.
• Qualified Person (QP) responsible for product release.
• QA Support for the development of new pharmaceutical products and production processes.
• Implementation of Quality Systems, including Trackwise.
• Conducting Internal and External Audits.
• Developing and Delivering Training Courses for pharmaceutical staff.
• Facilitating Risk Assessments and setting up environmental monitoring programs.
• Validation Support for production processes, cleaning validation, equipment qualification, and QC test implementation.

Previous Positions:

• QA/QP at Intravacc (2012-2015): Responsible for quality assurance and acting as Qualified Person.
• QA/QP at Abbott Biologicals (2007-2012): QA for the influenza development group, handling product complaints, and QP responsibilities.
• Consultant and Director at PCS (2004-2011): Various QA/QC positions for different pharmaceutical companies, including QP functionality and developing training programs.
• QA at Nederlands Vaccin Instituut (2005-2011): Support of the QA department, GMP improvement projects, and project manager for the implementation of QMS/DMS (Trackwise).
• QA/QC Manager at AMT Biopharma (2003-2004): Setting up and implementing quality systems for viral-based pharmaceuticals.
• QC Manager at Merck Sharp & Dohme (2000-2003): Daily management of the QC laboratory, responsible for analytical and microbiological analyses and environmental monitoring.
• QC Manager at Teva Europe (1995-1999): Managing routine QC analyses, technical transfers of QC tests, and setting up a laboratory for cytostatics.

Education:

• PhD in Radiopharmacy from VU University Amsterdam. Research focused on the development of new radiopharmaceuticals, with the thesis titled: "The suitability of Zirconium-89 for labelling of antibodies for positron emission tomography".

Experienced consultant with 40 years of expertise in virology, microbiology, aseptic processing, and analytical method validation. Possesses extensive experience with various quality systems such as GMP, GLP, and ISO 17025, and is familiar with guidelines from FDA, EMA, and ICH in the development of pharmaceutical products. Holds an MBA from Nyenrode Business University, enabling the effective application of this knowledge in new laboratories and where change is needed. Experienced in all phases of pharmaceutical development, from early research and clinical phases to commercial production.