Junior Qualified Person (FR/DU & ENG)
That's XPE. For one of our clients we are looking for: Junior Qualified Person (FR/DU & ENG) Organisation description:
Our client, a pharmaceutical company, located in Elsene/Ixelles, is looking for a Junior QP to engage permanently. As a Responsible Person / Qualified Person your role is to maintain, update and continuously improve an appropriate and sustainable Product Quality System and Quality Culture at the Country Office in order to ensure compliance with the company and Regulatory Authority expectations at all time. You will be, in absence or by delegation of the QO Lead, the main point of contact, for the investigation and resolution of all (product) quality issues discovered or originating in the Country Office and for interacting with the relevant local stakeholders (such as Regulatory Affairs, Medical, Global Supply Chain and Portfolio Management, Business Units) and Global Supply or Contract Operations Quality Assurance (COQA) on such issues. You will be the back-up Person Responsible for Good Distribution Practice (GDP) and the back-up Qualified Person (QP) for Good Manufacturing Practice (GMP) e.g. batch release following relabeling/repackaging operations for legal entities of the company.Job description:
Your responsibilities as a Junior QP will exist of: Product Quality System o Manage (deploy, update and maintain) an effective and sustainable Quality System. o Deploy and provide training for all applicable Functional Standard Operating Procedures (SOP) (issued by global Supply Chain Management Quality Operations) or Local SOPs within the PCO. o Supervise processes related to GDP (drug supply, stock management, stock availability, customer management, logistics complaint handling, T° monitoring and transport of products, product disposal…). o Supervise processes related to GMP (local relabeling & repackaging). Deviation Management (in conjunction with the GS Quality Operations) o Investigate Product Quality and/or Compliance issues/deviations that occur within the responsibility of the country organization. Reflect on preventive/corrective actions and ensure the proper execution and tracking. Local investigations may relate to product damage, artwork and labeling errors, counterfeit, temperature excursions during transport or issues with contract manufacturers or logistics service providers etc. Product Complaint handling o Support the management of intake and triage of product quality complaints (including medical devices) from the local markets (Belgium & Luxemburg). Supervise class, subclass and criticality assigned to product quality complaints and if required notification to the appropriate investigating GS/Contractor Site via the global complaints management system. o Supervise tracking of complaint responses. o Review and signs-off responses to complainants in a timely manner. o Review the product complaint form before sign-off for closure by the Lead. Notification to Management o Assess the need for and provide information to QO Management in case of significant deviations and complaints. o Attend, in absence or by delegation of the Lead, Area Quality Review Teams (AQRT) meetings, as principal CO representative, to provide the local perspective on requirements with regard to the issue. o Cooperate in writing or write AQRT Executive Summary for issues originating under the responsibility of the CO. o Ensure, in absence or by delegation of the Lead, the local implementation of actions identified during Area Quality Review Team (AQRT) meetings, e.g. recalls, communication with Regulatory Agency, local corrective/preventive actions. Local Contractor Quality Oversight o Support the lead with the development, negotiation and maintenance of up to date Quality Agreements with GMP/GDP contractors involved in manufacture, relabeling & repackaging, laboratory testing or activities at Logistics Service Providers. Oversee quality operations at contractors, which includes but is not limited to: Contractor Assessment and Approval: Ensure all GMP/GDP contractors have been formally assessed and approved. Deviation Management: Evaluate the impact of all significant deviations affecting safety, identity, strength, purity & quality (SISPQ), generated at the contractor and agree on corrective actions. If necessary, initiates the “Notification to Management” process. Quality System Support: Visit the contractor to assess quality systems, review quality performance and agree action plans to ensure continuous improvement. Include quality reviews during Business Review Meeting (BRM). Issue and review Metrics: Periodically assess the overall quality risk associated to the contractor. Act on adverse trends in order to improve contractor quality and compliance performance. o Support the Logistics Sevice Provider (LSP) in achieving/maintaining the companies Quality Standards and regulatory requirements, by acting as (first) point of contact. o Facilitate, together with the Lead, Manufacturing Supplier Quality Assessment (MSQA) audit process at the contractor(s). Help to define appropriate action plans for improvement and follow-up and communicate action closures. Inspections and Internal Audit o Support the Lead in the preparation and coordination of Regulatory Agency and internal inspections of Product Quality and Compliance (GMP/GDP) activities at the CO. o Support the Lead with the implementation of the identified actions within agreed timeframes. Oversight of local Repackaging and Relabeling Operations o Inform the releasing site of the repackaging/relabeling activity. o Review documentation related to the repackaging/relabeling operation. Development and Maintenance of Consistent Quality Culture o Provide ongoing education on Quality to relevant CO functional groups, to increase awareness and understanding of requirements and enhance the Quality Culture. Local BU support o Quality support for “Tender” filing at community level as well as at hospital level. o Quality support for Product Complaints. o Quality support for Business Continuity (BCP).Profile:
Minimum level of education o Master Degree in Pharmaceutical Sciences o Qualified Person certification according to the Royal Decree of 14 December 2006 article 84 and recognized by the Belgian Agency is an asset. Experience o Previous working experience in GDP is an asset. Technical/Functional/Professional Competencies Specific to the job o Have appropriate quality and technical experience to manage expectations. o Assess risk and make sound & effective quality decisions under pressure through analysis of data. o Diplomatic in communication with internal and external customers. o Show strong negotiation and effective communication skills. Is influential. o Self-motivated individual who is comfortable with working independently. o Able to lead and work effectively in cross-functional team & collaborate. o Build trust and credibility with internal and external business partners and Regulatory Authorities. o Move from an overall picture view to details and returns again, as situations develop and needs change (helicopter view and ability to priorities). o Computer literate. Languages o French or Dutch and English verbal and writtenOffer:
For this position you will be engaged permanently at our client. If you have questions or doubts? Don't hesitate to contact me!
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002 XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713