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COMPLIANCE SPECIALIST, GDP - Netherlands  

Company managed [?] Still accepting applications

Posted on : 26 June 2017

Project Description

RESPONSIBILITIES 
As a Compliance Specialist, GDP, you support company’s quality system and deal with customer quality requirements. 
 In general, you are responsible for:  
  • Evaluating the requirements for outsourcing warehouse activities; 
  • Coordinating with Supply Chain and Logistic service providers to ensure proper policies and procedures relating to GDP are in place; 
  • Monitoring validated transport packing for cool shipping and monitoring the controlled temperature for inbound shipment based on risk assessment; 
  • Monitoring and controlling GDP compliance for company’s current warehouses 
  • Maintaining logs and monitoring progress of change controls, CAPA’s and validations; 
  • Supporting implementation of a new document management system and departmental policies; 
  • Supervising procedures for handling narcotics and psychotropic products, as well as handling export of ephedrine and thiopental and other export restrictions (dual use goods) and boycott regulations; 
  • Ensuring that repackaging is performed according to current GMP practices and that outsourced processes are clear and concise; 
  • Checking and authorising packaging or labelling specifications; 
  • Performing Internal GDP audits for our company or for the outsourced warehouses; 
  • Providing training to the Sales and Supply Chain departments when required; 
  • Performing batch releases in case the responsible pharmacist is absent; 
  • Supporting sales /client requests for documentation and advice; 
  • Performing other tasks as required.    


REQUIREMENTS
 To be seriously considered, we require the following:   Education & Experience:  
  • Master’s degree in (pharmaceutical/biomedical) sciences or similar; 
  • Minimum of 5 years of relevant experience in quality assurance; 
  • Experience with an ERP system, preferably JD Edwards; 
  • Knowledge of quality standards and requirements for medical products; 
  • Familiar with basic GMP and GDP requirements.   


Skills & Characteristics  
  • Excellent communication and problem-solving skills; 
  • Ability to resolve matters in a process oriented way to ensure effective solution through the organisation; 
  • Excellent interpersonal skills and a strong team mentality; 
  • Works with attention to detail; 
  • Good computer skills, especially MS Word and Excel; 
  • Strong affinity with quality.  


Language 
  • Fluency in written and spoken English   


BENEFITS 
At our Foundation, we ask a lot of our employees, but we also give a lot in return. This includes:  
  • Great colleagues: You’ll work in a team of enthusiastic, motivated professionals in an open atmosphere 
  • Inspiration and development: We offer training and personal development opportunities for all employees, and regularly host guest speakers. 
  • Fun: Department and company outings are organized on a regular basis, and we make sure to celebrate our successes together. 
  • Making an impact: our company offers a great opportunity to use your passion and skills for good, while working in an enthusiastic team and stimulating environment. 
  • Salary and holidays: We benchmark salaries against mid-sized companies in the Netherlands, and to support a healthy work-life balance we offer 30 vacation days for a full-time contract. In addition, we offer a commute allowance and a defined contribution pension.