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:
o Developing and maintaining procedures
o Performing internal & external audits
o Following-up CAPA’s
o Establishing and updating quality agreements with customers, suppliers, distributors and subcontractors
o 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
1. You have a Master degree in Science (Chemist, Pharmacist, Bio-Engineer, Industrial Engineer,…)
2. You have a first experience in a QA function within the pharmaceutical or related industry.
3. You have knowledge about quality standards (GMP, ISO9001).
4. You are able to oversee all processes in and outside the company.
5. You are a good organiser & planner and you know how to bring structure in a complex matter.
6. You know how to deal with pressure and deadlines.
7. You have excellent communication skills in English. Any other language is a plus.
8. You have excellent IT-skills. Knowledge of SAP and Sharepoint is a plus.
Aanbod