Regulatory Affairs

**Functie**:
You will follow up the quality assurance and regulatory affairs activities for our AASO activities.

This includes:

- Providing regulatory affairs and technical services activities
- You provide quality and regulatory support to customers
- You collect information and documentation from the concerned manufacturers
- You organise the received information in a database
- You implement efficient systems to handle routine matters and questions
- You contribute to the organisation of customers audits.
- Providing quality assurance activities regarding Distribution
- You evaluate and maintain compliance with Pharmaceutical regulations (GMP), ISO 9001 quality standard and quality policies of AOC/AASO by:

- Developing and maintaining procedures
- Performing internal & external audits
- Following-up CAPA’s
- Establishing and updating quality agreements with customers, suppliers, distributors and subcontractors
- Managing and following-up the communication with suppliers, customers and partners with regard to quality complaints.
- Controlling the allocation of material codes to customers.
- Providing quality assurance activities regarding Import and Release of Pharmaceutical products
- You develop and maintain the quality system and documentation relating to the import and release
- You manage APR’s, follow-up deviations and CAPA plan
- You collect the batch release data and prepare the release documentation
- You manage temperature monitoring and data collection
- You communicate with subcontractors with regard to GMP and quality issues
- You coordinate quality actions and participate in audits performed by authorities and customers
- You report to the Regulatory Affairs & Quality Assurance Manager AASO.

**Profiel**:

- You have a Master degree in Science (Chemist, Pharmacist, Bio-Engineer, Industrial Engineer, )
- You have a first experience in a QA function within the pharmaceutical or related industry.
- You have knowledge about quality standards (GMP, ISO9001).
- You are able to oversee all processes in and outside the company.
- You are a good organiser & planner and you know how to bring structure in a complex matter.
- You know how to deal with pressure and deadlines.
- You have excellent communication skills in English. Any other language is a plus.
- You have excellent IT-skills. Knowledge of SAP and Sharepoint is a plus.

**Aanbod**: