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<pre>Array ( [var] => cut_url ) </pre> Resume for Hilde V. for Quality Assurance / Control / Biotechnology & Pharmaceuticals in Sosua, Dominican Republic. Search More Resumes for Quality Assurance / Control on Resumark.com #KACSBDCCE
 

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Resume for Hilde V. for Quality Assurance / Control / Biotechnology & Pharmaceuticals in Sosua, Dominican Republic




Occupation: Quality Assurance / Control Industry: Biotechnology & Pharmaceuticals
Country: Dominican Republic City: Sosua
State: Puerto Plata ZIP: 82000



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Curriculum vitae
Hilde V.
Born september
Belgian citizenship, living in the Dominican Republic
Education
Bachelor in biotechnology
Languages
Dutch, English, French, German knowledge
Career
Period from until – several consulting Interim jobs for various companies, consulting
in Document Mangement, QA roles, Quality Management, GCP, GMP and QC reporting.
Quality Assurance Auditor – PPD – from April until July interim via LabSupport
Senior Quality Assurance Auditor – Lab Corp bvba – from until
Conducting scheduled audits of the Clinical Trials operations of Lab Corp and if needed
their subcontractors, to assure compliance with GLP/GCP regulations. Audits cover both
technical aspects analysis, data audits and organizational aspects systems audits.
Coordinating QA activities with satellite facilities subcontractor laboratories and
suppliers. This involves international travel to perform onsite assessments.
Preparation of timely reports of the audit findings for distribution to management.
Responsible for the tracking and followup of the audit reports to resolution through the
review of corrective and preventive actions.
Attending of training courses to maintain proficiency in auditing techniques and to
maintain current knowledge of GLP/GCP regulations and company policies and
procedures. Specifically looking after any requirements related to software validation and
electronic data handling.
Responsible for the training of the audited departments and junior auditors in GLP/GCP regulations.
Advisor of audited departments on relevant standards.
Developing and maintaining an understanding of all functionality associated with each of the systems
applications. Specifically this includes Clinical Trials Management Systems, LIMS, Sample Storage
Systems and general office software such as Lotus Notes and MS Excel.
Evaluation of compliance of computer systems with stated requirements.
Writing and reviewing SOPs for the QA Department and reviewing SOPs for other Lab Corp departments
involved in clinical trials work.
Responsible organizational and staff for subdivisions in the Quality Assurance department document
management, complaint handling, Archiving, Training and Computer Validation to assure the efficient
functioning of the department and the success of the company.
Backup for Director of Quality Assurance to participate as a client liaison during
negotiations and client audits. Assisting as needed with regulatory inspections and
accreditation audits.
Development of General Policy concerning Validation of Computerized Systems and close
collaboration with the ITdepartment in developing further procedures for their
department.
Development of a Business Continuity Plan for the ITdepartment in close collaboration with the mother
company in the US.
Laboratory Supervisor British American Tobacco Belgium from until
closing of the factory.
Daily organisation of laboratory staff of and ordering of materials for laboratory.
Evaluation of staff.
Rebuilding of the chemical lab in order to be compliant with internal quality guidelines, implementation of
quality guidelines within the lab in preparation for future accreditation.
Member of several work groups in the production division quality steering group, specific subgroups for
production related issues, project member for several projects such as procedures database, menthol project,
study on LIMS and other data flow systems, exchange project with Quality Assurance Auditor from
Zevenaar.
Extensive collaboration with sister companies in Zevenaar and Bayreuth regarding smoking analysis.
Attending of seminars and conferences in general for the tobacco industry.
Member of workgroup "physical parameters for the tobacco industry" seat in Southampton, member of the
European Analytical Laboratory Group seat in Bayreuth, member of work groups involved in study’s on
developing standard smoking procedures within the tobacco industry.
Contact person for all chemical and smoking data coming from the Brussels’ lab for Brand Managers
regional, on area level and worldwide, responsible for internal quality reporting regarding own products
versus competitor.
Extensive collaboration with both Shift Managers on work floor to enhance production,
production flow and productions schemes.
Actively attending Senior Staff meetings to explain via datasheets, MS Excel macro sheets and various
graphics how Product Development evolved and how the interaction of P&D and Product Enhancement on
the work floor went forwards.
Additional training
Good knowledge of ISOguidelines, IKZ, EN , GMP, GLP, GCP and FDA rule for
Computer Validation.
Training modules CMS Competent Management Skills : People leadership, creative problem solving, meeting and
presentation skills, negotiation techniques,...
Training product knowledge in Southampton and Bayreuth.
Training modules in Internal Quality Assurance and Statistical Process Control, seminars on Accreditation and
Validation of laboratory results and ISOguidelines.
Attending of conference in London concerning Computer Validation en FDA rule .
Scheduled trainings on practical implication of Validation of Computerized systems writing validation plans, test
scrip’s and test procedures.
Pc knowledge
Broad experience with MS Windows, MS Word, especially MS Excel with writing of complicated
macro sheets and graphics attached to it, MS Powerpoint, good user knowledge of SAP, Lotus
Notes and Internet/intranet applications.
Personal skills
Accurate, a good eye for details, loyal, consequent, flexible, proactive, always willing to learn,
can work very independently.

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