Experience

Adryan

• Netherlands
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior QA/QC/GxP consultant

  • Feb 2016 - Present

  Adryan was founded in 2012 in Dordrecht. The founders, who are also responsible for the daily running of Adryan Consultants, have more than 20 years’ experience within the Benelux as a consultancy and service provider in the pharmaceutical industry. Adryan Consultants has fixed staff employees and freelancers who are connected in the Adryan Consultants network. With this network Adryan Consultants is able to solve your complex problems and/or fill in your gaps regarding: (QA/QC/RA/other) Compliance, Process, Production, Design, Engineering, Construction, Commissioning, Qualification and Start-up. Show less



MSD

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Interim Manager Analytical QC for Vet Farma Friesoythe (MSD AH) (on behalf of Adryan Consultants)

  • Jan 2019 - Present

  Interim Management position and expectations defined as a project, including milestones - Interim Manager AQC, leading a team of 16 analysts, running daily business, continuing running projects and starting planned new projects, Change Control, Deviation Management, Inspection programs etc. - Identify and hire successor for the position AQC Manager: hire for open positions - Reorganise AQC department to be fit for routine testing and future expectations, by defining and implementing: o Redefine Roles and responsibilities (RACI table) as well as an improved training matrix, and create people development opportunities o Identify and implement additional structural and practical improvements to increase the overall performance and efficiency of the AQC lab Show less



Bilthoven Biologicals

• Netherlands
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• QRD QA-projects QA compliance specialist (on behalf of Adryan Consultants)

  • Mar 2018 - Jan 2019

  Assignment: - Member of the team that is responsible for the qualification of the restructured production facility intended to be used for the commercial production of Polio vaccins - Member of Serialisation project team Assignment: - Member of the team that is responsible for the qualification of the restructured production facility intended to be used for the commercial production of Polio vaccins - Member of Serialisation project team



MSD

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr PQ Specialist for MSD Biotech GmbH Burgwedel (on behalf of Adryan Consultants)

  • Jan 2017 - Mar 2018

  Assignment: Member of the team that is resposible for the Performance Qualification of the newly build production facility (clean rooms class D to A), intended to be used for the commercial production of the Ebola vaccine. Assignment: Member of the team that is resposible for the Performance Qualification of the newly build production facility (clean rooms class D to A), intended to be used for the commercial production of the Ebola vaccine.



MSD Netherlands

• Netherlands
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Pharmaceutical Specialist for MSD Haarlem (on behalf of Adryan Consultants)

  • Feb 2016 - Dec 2016

  Assignment for MSD Haarlem: • My responsibilities and tasks: In the role of Pharmaceutical Specialist for the 3 departments Vaccines packaging, Blister and Specialties packaging: o Deviation management, investigation and CAPA o Customer complaint handling, investigation and CAPA o Identification of process and/or equipment improvement opportunities. Assignment for MSD Haarlem: • My responsibilities and tasks: In the role of Pharmaceutical Specialist for the 3 departments Vaccines packaging, Blister and Specialties packaging: o Deviation management, investigation and CAPA o Customer complaint handling, investigation and CAPA o Identification of process and/or equipment improvement opportunities.



Rescop

• Netherlands
• IT Services and IT Consulting
• 1 - 100 Employee

• Senior GxP Compliance consultant

  • Feb 2015 - Feb 2016

  Offering GxP compliance and Quality Assurance expertise. First assignment for Rescop: Smith & Nephew, Curaçao Deviation/CAPA investigation expert Team Lead Rescop team Curacao (team of 8 SME's) Work stream lead Deviation/CAPA remediation.(leading 15 (Sr) investigators) Offering GxP compliance and Quality Assurance expertise. First assignment for Rescop: Smith & Nephew, Curaçao Deviation/CAPA investigation expert Team Lead Rescop team Curacao (team of 8 SME's) Work stream lead Deviation/CAPA remediation.(leading 15 (Sr) investigators)



Basic Pharma

• Netherlands
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Manager Quality Assurance

  • Feb 2014 - Feb 2015

  Basic Pharma Manufacturing is a small but fast growing company for generic prescription and OTC products, specialised in crèmes, ointments, nasal spray products and (sterile) IMPs. Production is executed in cleanrooms and where applicable in sterile cabinets under full GMP regime. Main achievement: Setup and perform a remediation program restructuring the QA department improve major programs like Deviation/CAPA and Change Control etc., re-obtaining GMP certification within 5 months. Main responsibilities and tasks: • MT Member • Leading the Quality Assurance department • Guide and control the structure, improvements and maintenance of the pharmaceutical QMS, quality manual and GMP within the organisation • Review and authorisation of Master QA documents • Change Control, CAPAs, deviations and complaints • Setup and perform GMP training programs • Assessment of suppliers / CMO’s / service providers; • Perform Risk Assessments • Management of audits • KPI monitoring of the QA-department Show less



MSD Animal Health

• Boxmeer

• Document Management Officer

  • Jun 2010 - Jan 2014

  MSD Animal Health is the 2nd largest company (worldwide) for medicines, vaccines and drug administration devices for veterinary use, licensed in approx. 140 countries. My position as Document Management Officer was in the Information Management and Compliance Team (within Global Regulatory Affairs), supporting the department and the Country Operational Regulatory Affairs groups in the different countries. My responsibilities and tasks: • Support the GRA department by identifying and improving business processes necessary to obtain and maintain market authorizations, while improving efficiency and minimizing time to market. • Group leader to recruit, supervise, and coach the document management team, consisting of 2 employees in Boxmeer, 1 in Schwabenheim, Germany, and 1 in Anger, France. • Representative for MSD AH in the IFAH-Europe, a Veterinary Industry representation group in Brussels aimed at aligning industry needs with governmental requirements. As such, I also represented IFAH-Europe in meetings and discussions with authorities concerning the EMA guideline on e-submissions and CESP (Central Electronic Submission Platform) • Supervise and verify the quality of the electronic presentation of European dossiers based on the EMA guideline on e-submissions for veterinary medicines. • Administration of supporting IT-systems and applications, electronic archives, shared drives, SharePoints, Document management systems and dossier compiling tools (Lorenz Docubridge, eCTD Office) • Business Architect (as system owner) for new IT systems and updates for existing systems, translating the business needs into URSs, functional specs and functional test cases for system qualification, ensuring that all business needs are supported as required and that the applications perform as expected. Show less



DSM Pharma Chemicals Venlo

• Venlo

• Quality Assurance Officer

  • Jul 1990 - Jul 2010

  DSM Pharma Chemicals Venlo is mainly focussed on the production of Active substances and precursors for the Pharmaceutical Industry. As one of the Quality Assurance Officers at the Venlo site, I was responsible for the full scope of Quality Assurance. This includes: • QA Manual: Administration of the (quality) management systems (including ISO 9001, 14001 and DSM internal SHE requirements) and documentation (Policies, SOPs and instructions) • Perform and report Management quality reviews (ISO 9001) • Draft PQRs (product quality reviews) • Draft and maintain the Site Master Validation Plan (SMVP) • Support in drafting quality contracts with customers and suppliers. • Perform and report internal audits/self-inspections for ISO 9000 and GMP • Draft improvement plans based on the results of the internal audits. • Perform external audits (Vendor Qualification, ISO 9000 and GMP) • Leading customer audits and inspections (ISO9000, GMP and CEP certification) • Draft and maintain Drug Master Files (CTD format) • Conduct GxP and Quality trainings. • Product release including batch production record reviews, IPCs and OOS (QP role) • Deviation management (CAPA), root cause analysis. • Release of raw materials and packaging materials. • Customer complaints and internal complaints. • Recall procedures. • Change management (in a leading role for all QA related changes) • Administration of raw material, intermediate and finished product specifications. • Review and approval of procedures (SOPs), instructions and (master) production documentation (including raw material handling and sampling in cleanroom) • Review and approval of stability studies. • Qualification/validation/evaluation of equipment and processes • Qualification/validation/evaluation of suppliers of services and goods (internal and external) • Review and approval of (early) development processes; from Proof of Concept (PoC) through pilot plant (production process establishment) to commercial scale production. Show less