Quality System Specialist Deviation Management
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The Quality System specialist Deviation Management is the local expert for Deviations & CAPA. He/she:
- Coordinates the deviations & CAPA quality systems for the site and ensures compliance with global and local regulatory requirements and customer expectations at the system level
- Ensures best practices are in place and in use, seeks for continuous improvement, while ensuring application of the right level (risk-based approach) of quality
- Assures capabilities buildup within the site through effective coaching, monitoring/reporting, and performance management.
- Will be the main contact person for implementation of the Deviation Champion Program on the site
Major Responsibilities
- Definition and follow-up of deviations & CAPA roadmap for the PolyPeptide Braine site. To evaluate and lead continuous improvement initiatives (i.e. Site Quality Plan) concerning deviations & CAPA, to ensure compliance with quality systems, global requirements, regulations, guidelines and customer requirements.
- Developing and maintaining the Quality Management System in relation to deviations & CAPA: evaluate the performance management of deviations & CAPA, make results visible through KPIs and periodic reports, share the results during Quality Council, Site and PPL Group community and propose improvements.
- To manage the creation, review, maintenance and delivery of deviations & CAPA training material. Train, coach and mentor on the job PPL personnel on deviations & CAPA management principles and RCA tools from onboarding to increased maturity.
- To review and maintain documents related to deviations & CAPA in accordance with current quality system requirements, regulations, guidelines, and customer expectations.
- Establishment and leading an internal site network of deviations & CAPA champions and actively participating in creation of global multi-site deviations & CAPA community of practice within PPL group. Be the PPL Braine point of contact for Braine site within the PPL group.
- To perform internal audits and act as an SME during internal and external audits and inspection for deviations & CAPA topics, redacting responses and managing the associated follow-up actions.
- Backup of the Quality System Change Control Specialist
- To follow external complaints received from customers as well as recall (or mock-up)
- To be the main contact person for the Deviation Champion Program which consist of :
- Improve the quality of investigations and the RFT during deviation review => impact on QIP Key performance Indicator « deviation Timeliness »
- Reduce recurrence of deviation through effective CAPAs addressing the true root cause => impact on QIP Key performance Indicator « Deviation recurrence rate » and « CAPA timeliness »
- Minimize customer intervention / regaining ownership of the process
- Adherence to timelines
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