Quality System Specialist Deviation Management
- CAPA
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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:
1. 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
Quality System Specialist Deviation Management · PolyPeptide Belgium