Quality Associate III-QO Systems Lessines, Belgique
Since October 2014
§ Support the Compliance to cGMP’s, cGLP’s, GDP’s and Baxter Procedures by defining and maintaining partnership between Quality and Operations
§ Support the adequate deployment, implementation and utilization of all quality systems as defined by Baxter Procedures.
§ Perform GMP walkthroughs during routine operations
§ Act as a quality link on the floor to support adequate quality systems deployment and application.
§ Participate to QIT.
§ Support any quality decision on the floor in coordination with Quality Control. Provide support and expertise in all quality-related issues.
§ Participate, lead investigations (Problem Solving, CAPA) and continuous improvement projects (DMAIC, Kaizen).
§ Provide support in the development and deployment of training.
§ Supports any process/facility/equipment/test method modification by participating to the quality requirements definition.
§ Exception Management (ER, NCR, CAPA, Complaints/AE)
o Participation to weekly meetings.
o Act as Quality Representative in the quality impact evaluation , the investigation (including quality impact) and the approval of ERs/NCRs.
o Assist, review and approve ER to ensure adherence to quality systems.
o Supports timely closure of Exception Reports according to applicable procedures.
o Assist in performing complaint or adverse event investigations.
o Participate in or lead CAPA process investigation, as needed.
§ Change Control
o Supports timely closure of Change Requests.
o Act as a Quality Representative to review and approve documentation changes and notifications of interventions.
o Routine Requalification.
o Review standard requalification for laboratory equipment/system.
o Give support to the Quality Control and Validation services for the execution of protocols in terms of improvement projects.
o Continuous improvement of documents in direct partnership with Quality Control.
o Support GLP
o Support Pharmacopeia updates
Validation Engineer Lessines, Belgique
October 2012 --- September 2014
1. Prepare and implement the validation documentation required to assure the development of a project and support regulatory submissions.
2. Act as a validation representative for projects:
a. Define and implement all validation activities related to the project.
b. Develop the Validation Plans: define validation methodology and approach.
c. Provide validation expertise and quality assurance guidance for the development of the project.
d. Participate in the risk assessment.
e. Review URS, FS and DS for validation requirements and all applicable QA/RA requirements.
f. Prepare and implement FAT, IQ, OQ & PQ protocols.
g. Assure requirements traceability throughout the whole project validation file (from URS to PQ).
h. Organize and coordinate FAT, IQ, OQ & PQ validation activities with the different departments (on the ground, as required) in such a way that all of them concur with the timeframes committed with the project leader.
i. Analyze, interpret, document and report the testing results.
j. Ensure the follow-up and tracking of the validation activities. Update the validation documentation system.
k. Assure feedback of status and issues to QE department head.
3. Provide support in all quality-related issues (GMP regulations, compliance, internal SOPs, and all aspects of safe, reliable and consistent operation of the system).
4. Evaluate, analyze and approve deviations and changes in order to guarantee that these are well documented and that corrective actions are taken and followed-up upon.
5. Take part in audits.
6. Revision and approval of change control documents (DCR, CR, NI, etc) as a Quality representative.
7. Provide the required information to support the preparation of facility & process related files for the various regulatory agencies.
8. Review the Change Requests related to their part of the business and evaluate the impact and validation requirements related to the modifications. Verify that the changes are correctly performed and documented.
Bulk Chemical Technician Lessines, Belgique
September 2009 --- August 2012
Effectuer toutes les opérations requises par les process Gammagard Liquid / Gammagard SD / Tetabulin / Subcuvia :
o Préparation de solutions
o Filtration frontale et tangentielle
o Opérations de contrôle qualité In-process :
o Mesure /ajustement de pH, conductivité
o Dosage IgG, IgA et Na par spectrophotométrie
o Tests d’intégrité des filtres stérilisants
o Garantir le maintien en état des zones et équipements de production :
o Cleaning journalier et mensuel en support du team BMS
o CIP des cuves
o Sanitisation et drainage des circuits d’eau
o Respect des principes 5S appliqués dans le département