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Olivier Vanoppen
Industrial Pharmacist with registration as Qualified Person (QP)
Managing Partner – Founder
Olivier has extensive experience as a Qualified Person and QA manager within various pharmaceutical companies. With twenty years of experience in the operational environment, Olivier is a specialist in developing new processes for both clinical and commercial medicines.
Characteristic is his pragmatic approach, tailored to the organization, and taking into account the needs and possibilities of the organization.
Within Farma Consulting & Partners, Olivier is responsible for defining the strategy, recruiting new talent, and developing new services.
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Inge Keunen
Master in Biomedical Sciences with financial expertise
Managing Partner – Founder
After her studies, Inge entered the financial world where she further specialized in providing financial and tax advice. Afterwards, Inge focused on a postgraduate degree in Business Administration at KU Leuven. Furthermore, Inge took a Master Class in HRM at the Antwerp Management School to further develop her capabilities.
Within Farma Consulting & Partners, Inge takes on the core task of Managing Partner, whereby she takes care of the financial & HR management because of her background. Inge is also partly responsible for setting out the strategy and general policy within Farma Consulting & Partners.
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Thomas Eerdekens
Industrial Pharmacist with registration as Qualified Person (QP)
Partner
Thomas gained experience within various manufacturing processes, environments and company structures. Characteristic is his hands-on mentality, combined with his ability to bring structure to complex situations. He specializes in setting up & improving quality processes within various regulatory frameworks (including clinical pharmaceuticals, commercial pharmaceuticals, API, ISO 13485:2016 and ISO 9001:2015). Additionally, he has also gained extensive experience in general QA functions, allowing him to take on the role of QP as well.
Within Farma Consulting & Partners, Thomas is responsible for supporting our customers within quality management. He acts as an SME in implementations of QMS systems and optimizations of existing processes.
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Jan Buyle
Industrial Pharmacist with registration as Qualified Person (QP)
Jan has built up a broad technical background as an Operational Excellence Deployment Lead within commercial aseptic production as well as quality control of vaccines, parental and ophthalmic products. He has extensive experience in executing complex Six Sigma and LEAN projects and in deploying Operational Excellence cultures.
Within Farma Consulting & Partners, Jan is responsible for supporting our customers within the project work. He acts as an SME on LEAN and Six Sigma projects and statistics.
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Jonas Van Dingenen
Master in Drug Development with PhD
Jonas has built up extensive expertise as a release engineer within commercial aseptic production (including parenterals, ophthalmic products and vaccines). He also has experience with complaints handling, project follow-up and product release.
Within Farma Consulting & Partners, he is responsible for supporting our customers with his QA expertise. He acts as an SME within aseptic production.
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Lars Pinxten
Master in Biochemistry
Lars has extensive experience within QA, validation activities and quality systems. He has gained extensive experience at both small organizations, as large pharma and medical devices companies.
Within Farma Consulting & Partners, Lars is further responsible for substantively supporting projects within the broad QA domain. Given his strong background in QA and QC activities, Lars can provide support to clients within several aspects related to quality management.
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Clara Huyghe
Industrial Pharmacist with registration as Qualified Person (QP)
Clara has experience within the pharmaceutical sector supporting in the branches of validation, QA and as a QP. By working for several CMOs – each with a broad range of customers and processes – she has gained extensive knowledge in quality systems, processes and regulations related to pharmaceuticals, medical devices, cosmetics and food. Thanks to this experience, Clara is also an expert in preparing, supervising and following up on quality audits. In addition, she has a healthy interest in the validation and startup of utility systems such as purified water, air purification and compressed air.
Within Farma Consulting & Partners, Clara is responsible for supporting our clients within quality management, QA and QP services. She acts as SME in implementations of QMS systems and optimizations of existing processes.
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Lien Secretin
Industrial Pharmacist
Lien has a master’s degree in drug development and is currently finalizing her accreditation as a QP.
She has already gained experience within the QA department of an analytical (contract) lab, specializing in method development and validation. She also has experience with distribution and release of clinical supplies (IMP), additional labeling activities and use date extensions.
Within Farma Consulting & Partners, Lien is responsible for supporting our clients with her QA expertise.
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Julie Deckers
Master’s degree in Industrial Science.
Julie gained experience as project coordinator in serialization projects and as a process engineer in API production focusing on both chemical and powder manufacturing. She is experienced in the optimization of existing processes and the implementation of new processes across various production and QA departments.
Within Pharma Consulting & Partners, Julie is responsible for supporting our clients within project management, QA and QC domains.
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Dorien Vanvoorden
Master in Biomedical Sciences
Dorien has already gained experience as a QA assistant and then advanced to the position Head of QC and Interim QA Manager. During these positions, Dorien gained relevant experience about maintaining and overseeing a quality system.
Within Farma Consulting & Partners, Dorien is responsible for supporting our clients within QA and QC domains and can provide support for your quality processes.
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Sofie Pellens
Master in Biomedical Sciences
Sofie has her master’s degree in Biomedical Sciences and is responsible within Farma Consulting & Partners for supporting our clients with her accumulated expertise.
Sofie is familiar with the ISO 13485:2016 guideline and guides our clients in setting up an efficient quality system that meets all the necessary requirements. She also has experience in working out processes, documenting & coordinating the implementation of electronic batch records.
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Sam Beckers
Industrial Pharmacist
Sam has a master’s degree in Drug Development and is currently combining his assignments as a consultant with a master’s degree in Industrial Pharmacy. He has already accumulated experience within the QA department of a CMO and currently serves as a Quality Management Specialist and deputy RP.
Within Farma Consulting & Partners, Sam is responsible for providing broad support to our clients within QA.
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Abdul-Ghaffãr Guiry
Bachelor in Biotechnology
After his Biotechnology studies, Abbie gained experience within Quality Control, monitoring and optimization of production processes and development of innovative end products from by-products within the food industry.
Within Farma Consulting & Partners, Abdul is working on projects within the QA domain, acting as QA officer for Pharma as well as Medical device companies.
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Pieter Stas
Master in Industrial Sciences ICT – Electronics
Pieter has an academic background in IT but, has held several QA and CSV positions over the years through consulting, fixed price projects and as an internal employee. Although he gained his first QA experience during a project for the European Commission – Taxes and Customs, his interest quickly turned to Life Sciences and so since 2011 he has been working within major Pharma players as a CSV consultant, and as Quality Officer/Quality Manager at a CRO, IVD Authorized Representative and an IT Medtech SME.
Pieter accumulated knowledge and certifications on ITIL, CISA, Gamp 5, GxP, GCP and ISO 9001:2015, ISO 13485:2016/MDR, ISO 14971:2019 and GDPR, among others, and with that baggage he enjoys helping clients at Farma Consulting & Partners.
Within Farma Consulting & Partners, Pieter enjoys supporting clients with Computerized System Validation, Audits & Assessments and implementation projects of QMS and IT systems.
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Joran Smout
Industrial Pharmacist with registration as Qualified Person (QP)
Joran is an industrial pharmacist by training and has already gained experience as a QA Manager and QP at a CMO specializing in oral solids. Furthermore, he has experience in process and cleaning validation.
Within Farma Consulting & Partners, Joran is responsible for supporting our clients on QA and release projects.
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Fréderique Michiels
Master in Biomedical Sciences
Fréderique has experience within quality assurance (batch record review, deviation handling and validation (packaging equipment, CSV, etc)).She worked with a couple of QMS systems (Phoenix, Trackwise and Veeva Vault) and, also with a lot of other systems (Event Viewer, Trend Reporting Tool, LIMS, etc).
Within Farma Consulting & Partners, Fréderique now works as MES engineer. However, she can also serve customers with her QA knowledge
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Laïs Gryffroy
Industrial Pharmacist with registration as Qualified Person (QP)
Laïs has a background in the pharmaceutical industry within Quality Assurance and as a QP. She has worked as a Responsible Person (RP) for Good Distribution Practices (GDP) and pharmacovigilance in small and medium-sized enterprises (SMEs). Laïs has developed in-depth expertise within quality systems, aseptic manufacturing processes, and pharmacovigilance for pharmaceuticals and medical devices. Her experience makes her a skilled professional in preparing and supervising quality audits.
Laïs has assisted in the development of a quality management system and has experience in handling complaints, both quality-related concerns and safety complaints. Within Pharma Consulting & Partners, Laïs is responsible for supporting our clients within QA.
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Jan – Douwe Wieërs
Master’s in Bioscience Engineering
Jan-Douwe has demonstrated expertise in project management, system validation, and process optimization. This experience was gained in small SMEs as well as with major players in FMCG and Pharma.
At Farma Consulting & Partners, Jan-Douwe provides clients with support in project management.
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Britt Vranken
Master in Pharmaceutical Sciences
Britt has a master‘s degree in drug development. After her studies, Britt gained experience within innovative drug delivery and as a scientific writer. She also has experience within validation activities and during these positions, Britt has built up knowledge about project management.
Within Farma Consulting & Partners, Britt is responsible for supporting our clients within QA.
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Lieze Schruers
Master in Biomedical Sciences
After her studies, Lieze gained knowledge in QC and QA in a technical environment. While striving for quality, she learned how to handle stressful situations and optimize processes. She transfers this knowledge to the pharmaceutical industry for maintaining quality systems.
Within Farma Consulting & Partners, Lieze is responsible for support in QA, quality management and handling complaints.
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Nishtha Tiwari
Master in Bio-Engineering Sciences
Nishtha has a Master’s degree in Bioengineering with a major in Biochemical biotechnology. She has already built up experience within international and multicultural companies and has developed in-depth knowledge of project management, risk management, QMS, audits, process validation and regulatory compliance. Her experience makes her a competent professional in managing, leading and improving quality processes and related projects in the Life Sciences & Healthcare sector. Nishtha also has broad knowledge of GxP, MDR, ATMP, ISO 9001:2015, FDA and EMEA guidelines and regulations. She has also obtained certifications for ITIL, Prince2 and Lean Six Sigma, among others.
Within Farma Consulting & Partners, Nishtha is responsible for supporting projects around quality management, QA and QC.
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Luna Wallraf
Master of Drug Development
During and after her study Master of Drug Development at KU Leuven, Luna gained her first work experience within QA departments of both a small SME, and a large multinational.
Subsequently, Luna further expanded her knowledge within the field of Validation & Qualification with a focus on validation of small equipment within the production environment.
Within Farma Consulting & Partners, Luna is responsible for supporting our customers in validation projects.
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Sien Daniels
HR & Office Manager
With her background in Work and Organizational psychology, Sien enthusiastically fulfills the role of HR and Office Manager. With her expertise in understanding and addressing interpersonal dynamics within organizations, Sien creates a supportive work environment in which our consultants can thrive.