Providing Quality Leadership of assigned vendors within the small parcel, Global logistics network, whilst working to support the individual and holistic needs (Technical, communication and regulatory needs) of the Quality Operations and compliance team members for Global Small Parcel Logistics Operations.Working to lead the development, implementation and support of QA/QC systems for Global Logistic network partners, and supporting new product launches and network logistics operations.… Show more Providing Quality Leadership of assigned vendors within the small parcel, Global logistics network, whilst working to support the individual and holistic needs (Technical, communication and regulatory needs) of the Quality Operations and compliance team members for Global Small Parcel Logistics Operations.Working to lead the development, implementation and support of QA/QC systems for Global Logistic network partners, and supporting new product launches and network logistics operations. As a VQM I work to drive the development, implementation and continuous improvement of Quality Systems to support Pfizer, regulatory and industry requirements, whilst carrying out vendor selection and onboarding activities, determining vendor requirements such as:Partner with internal and external colleagues to develop and negotiate quality agreements, standards and contracts. Onboarding New Vendors, initiating new vendor questionnaire assessment, performing evaluation, selection and on-boarding including drafting QTAs, Standards and Contracts for Vendors, and supporting e-Quals SMS updatesProviding vendor support and escalation, working to support the operational team in vendor inquiries where escalation is required queries (e.g. CUSU report). Show less

Supporting real time monitoring and control tower Intercompany Logistics Operations for Global Small parcel network operations (Specifically Covid 19). Working to drive the development, implementation, and continuous improvement of Quality Systems to support Pfizer, regulatory, and industry requirements.• Ensuring implementation of an effective quality system and process improvements based upon determined remediation activities.• Leading quality risk management activities and manage… Show more Supporting real time monitoring and control tower Intercompany Logistics Operations for Global Small parcel network operations (Specifically Covid 19). Working to drive the development, implementation, and continuous improvement of Quality Systems to support Pfizer, regulatory, and industry requirements.• Ensuring implementation of an effective quality system and process improvements based upon determined remediation activities.• Leading quality risk management activities and manage mitigation plans within contract logistic carrier operations including first class freight forwarders and white gloves service transporters. Including the participation in lanes risk assessment and transport qualification solutions.• Working effectively with a global team to support the development, implementation and continuous improvement of Quality Systems to support Pfizer, regulatory and industry requirements.• Review of Technical, operation and physical qualification documents.• Proactively tracking investigations within QTS and eQMS (Yellow Belt Trained).• Working with internal and external colleagues to develop and negotiate quality agreements and contracts. • Provide support for deviations at contractor/partner logistics operations that may impact compliance status or require regulatory notifications. • Ensuring implementation of effective CAPA and quality system improvements based upon determined remediation activities. • Preparing ad-hoc SQRT, routine SQRT and AQRT summaries and participate in relevant meetings. • Leading quality risk management activities and manage mitigation plans within International Operations for COVID 19 Vaccine transportation.• Supporting the on-time disposition of commercial products within the supply chain. Show less

Contract Pharmaceutical GDP Quality Assurance specialist and Gold Standard Responsible Person registered with the MHRA, working with several clients to support the development, implementation and review of QA activities and quality processes in line with business development and current regulations. Offering support to clients during their MHRA, FAGG, HPRA and Home Office inspections, aiding with post-inspection responses and implementing identified Corrective actions required to gain… Show more Contract Pharmaceutical GDP Quality Assurance specialist and Gold Standard Responsible Person registered with the MHRA, working with several clients to support the development, implementation and review of QA activities and quality processes in line with business development and current regulations. Offering support to clients during their MHRA, FAGG, HPRA and Home Office inspections, aiding with post-inspection responses and implementing identified Corrective actions required to gain their Wholesale Distribution Authorisations and GDP Compliance Certificates. Carrying out quality functions, some of which included:• Maintaining and utilising the change control, deviation and corrective and preventative action management system• Maintaining the required training records for all GDP related staff against all relevant internal and client SOPs and assisting the RP with the creation of training matrix for personnel.• Client training – developing, updating and delivering training materials • Conducting annual refresher training for both GDP and the Falsified Medicines Directive, as well as developing and updating the training material for these sessions, to ensure compliance with the latest regulations.• Conducting initial and annual customer/supplier evaluations in line with EU requirements.• Resolving quality issues / complaints with the necessary changes and improvements.• Using Key Performance Indicators to monitor how successfully the clients QMS is operating.• Organising, monitoring and documenting the disposition of returned product.• Scheduling and being involved in the conduction of dummy recall exercises for clients, when no live recall had occurred.• Advising and supporting the client with any regulatory based communication or queries.• ISO 9001 and GDMP Audit trained, with audit experience - conducting audits and writing audit reports• Thorough understanding of current EU Regulations and Guidelines including GDP, GMP and ISO 9001 Show less