Compliance Specialist, GDP
fulltime position (40 hours/week)
In your role as Compliance Specialist, GDP (Good Distribution Practices) you are part of the Quality Affairs team, you report to the Director Quality Affairs and are responsible for maintaining GDP with focus on storage and transport conditions, as well as on process of outsourcing warehouse activities.
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.
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 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.
Do you have a strong affinity with IDA’s mission and are you interested in this challenging position? Apply now. Please note that we will only consider applicants who are currently living in the Netherlands and match the job requirements.
For questions regarding the vacancy, please contact Lien van Gogh (020-4109966). The candidate will be asked to hand in a Certificate of Good Conduct (Verklaring Omtrent het Gedrag) upon entering employment.