QA Distribution (GDP)
Wavre – Contracting
Our partner is looking for a QA GDP to join its team. The purpose of the mission is to support the Quality for Supply Chain team, being a quality partner for some of the distribution related activities. The mission also consists in supporting the operational quality assurance management of Wade Distribution Center. The objective is to ensure the continuous supply of vaccines in line with regulatory, quality and business objectives to meet customer needs.
What are the responsibilities?
Quality partner for deviations:
• Be the QA representative for CAPA on Wade operations, ensuring those are properly performed, following relevant procedures. Ensure implementation follow up is performed and escalation process is properly applied when needed.
• Support the monitoring of quality KPIs for Wade distribution center related activities through the preparation / lead of the monthly quality governance meeting (Quality Council). Ensure that periodical reviews are performed, and negative trends are properly remediated and escalated as required.
• Support archiving management of QA documents in Wade
• Review and approve self-inspections performed by Wade operations and ensure appropriate actions are identified to address the observations. Ensure follow up of the action plan. Perform self-inspections of the department activities following the self-inspection planning, ensuring due date are respected.
• Act as QA reviewer for procedures / ways of working. Be the QA representative in the Wade weekly SOP governance meeting an ensure the planning of review is realistic. Perform SOP / WOW QA review accordingly and ensure comments are discussed and implemented.
• Support update/review of the department owned SOPs.
• Coordinate monthly KPI meeting: extract data, prepare slides, align with stakeholders as needed.
• Promote continuous improvement mindset in a day to day activities within the team and peers by using Operational Excellence tools (e.g.:IPO/PSS/Fishbone/5S…)
• Participate in the management of team performances through regular shopfloor presence
• Coordinate DRA (Distribution Risk Assessment) performance with relevant stakeholders, ensuring adherence to the plan.
• Coordinate WDA (Warehouse Distribution Authorization) qualification process (i.e. pre-work with LOCs, WDA pre-assessment before upload to Veeva)
• Collect inputs from relevant stakeholders to be shared with the auditing team for Audits to LOCs.
• Rixthermo centralised mailbox: filtering, analysing mails received to prepare Tier meetings
Your profile ?
• 3-5 years of experience as QA in a pharmaceutical /biological production environment
• Scientific background is required
• Knowledge of Good Distribution Practices, including cold chain management.
• Risk based approach methodology adept
• Knowledge of regulatory, GMP, GDP and legal requirements relating to QA needed.
• Good knowledge and expertise of quality systems, e.g. CAPA, Documentation Management, Training
• Demonstrated capabilities in SAP
• Fluency in French. Full level of English written and spoken
• Good communication skills, proactiveness, independency, critical thinking and analysis of issues, impact and influence, innovative thinking, engage people, achieving excellence
• Easy collaborative & networking capabilities
• Agile mindset
• Result-oriented – delivery on time
• Team player
Our offer ?
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.
Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
