The Country Quality Release Officer is part of the Country Quality organization, which creates, maintains and monitors the quality management system.
More specifically, the Country Quality Release Officer is mainly responsible for preparing and/or performing market and distribution release of medicinal products and medical devices and for providing administrative support to the QP(s) performing batch certification.
The Country Quality Release Officer is also responsible for the maintenance of the applicable procedures and compliance to the current legislation, and for deviation management within his/her area of responsibility.
- Perform duty of care checks for all batches of medicinal products and medical devices (transport conditions and documentation thereof, availability and completeness of batch documentation, correctness of used printed packaging materials) and this in accordance with the registered product specifications and with national and international legislation
- (Support in) release for market and distribution of medicinal products and medical devices
- Administrative support to the QP(s) performing batch certification
- Deviation management within his/her area of responsibility (transport and artwork deviations, etc.)
- Prepare, review or approve local NCQ standard operating procedures within his/her area of responsibility
- Support in the preparation and execution of local repackaging activities (components check, release for artwork, etc.)
- Support in the artwork quality review
- Support in Change Control, GMP inspection / audit readiness and CAPA follow-up within his/her area of responsibility
- Participation in the NCQ organization’s back-up system to ensure business continuity
- Create and maintain strong collaborative relationship with internal & external customers (such as warehouse and manufacturing sites)
- Ensure training compliance