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COMPLIANCE SPECIALIST, GDP Amsterdam Netherlands,  


Posted on : 26 June 2017

Project Description

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RESPONSIBILITIES As a Compliance Specialist, GDP, you support IDA’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 IDA’s current warehouses (in Amsterdam, Veenendaal, and Schiphol); 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 IDA 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 IDA 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: IDA 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 fulltime contract. In addition, we offer a commute allowance and a defined contribution pension.

Locations

Amsterdam The Netherlands

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