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.
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.
- Fluency in written and spoken English
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.