Distribution Quality Specialist
Provide Quality support on Logistics and Display and Packaging related activities within the supply chain to assure quality of GSK HC products during packaging and distribution. Ensure that operations performed by the third party labor provider(s) and Logistics Service Providers and Distributors comply with the requirements of the GSK QMS and meet all relevant GMP/GDP regulatory and legislative requirements.
Ensure GSK HC Logistic activities comply with GDP for products received, inspected, stored, handled, and further distributed by GSK. Perform release-to-market activities in SAP involving confirmation of batch release, temperature monitoring evaluation, and reconciliation of product quantities.
Provide support to the Quality Distribution & Logistics Manager in the continuous improvement, harmonization, and establishment of Quality systems. Support warehouse and distribution facilities / operations, contract operations, logistics, product/process improvements, eliminate barriers, and investigate quality issues using applicable process improvement and problem solving techniques to assure successful outcomes of audits and Health Authorities inspections in all assigned sites/companies.
Provide Quality oversight and support for display packs & repackaging activities, performing compliance-related aspects such as review/approval/release to market, review and approval of validation activities, taking part in project teams, and maintaining business continuity in a seamless, compliant manner.
Work with the business partners to ensure that the Quality activities within the distribution chain operate in a cost-effective and efficient manner and maintain an innovative approach based on productivity improvement and implementation of best practice while maintaining appropriate levels of quality and compliance.
• Have strong knowledge base in GDP- related topics
• Assist Quality Logistics & Distribution Manager in the implementation of GSK HC Quality standards and cGMP requirements within assigned Display and Packaging and Regional Distribution Centers and Logistics Service Providers.
• Serve as backup to the Quality Logistics & Distribution Manager in supporting Logistics and Display and Packaging activities. Problem solve and provide shop-floor support to third party laborers performing Display & Packaging activities.
• Remain current on new regulations related to Distribution and Logistics and training requirements, ensuring activities are performed compliantly.
• Provide suggestions for resolution of quality issues impacting logistic operations to the Quality Logistics & Distribution Manager, ensuring issues requiring formal escalation are brought to the Quality Logistics & Distribution Manager's attention within established timeframes.
• Ensure that investigations, effective CAPAs and change controls associated with Logistics, Distribution and Display and Packaging facilities are properly performed, documented, evaluated, and closed timely as per procedures.
• Assist the audit team in audit preparation and participate in the audit execution of assigned warehousing and distribution facilities
• Review, approve and release display packs ensuring strict adherence to cGMPs. Ensure non-conformances discovered during review are identified and escalated appropriately.
• Assist the Quality Logistics & Distribution Manager as needed in activities such as Quality Agreement implementation, recall activities, audit commitment activities, self-inspections, and inspection readiness activities.
• Perform written gap analyses of relevant QMS documents to SOPs and make appropriate corrections to increase compliance.
• Provide support for all display and packaging related activities as it relates to quality
• Manage temperature excursions which occur during shipping
• Perform release-to-market activities, with ability to communicate effectively with sister distribution centers and business partners.
• 1-2 years prior experience in a related role in the Pharmaceutical or Consumer Healthcare industry
• GMP/GDP knowledge and ability to identify and ensure resolution of compliance issues
• Operational Quality experience
• Problem identification and solving skills
• Good leadership skills
• Excellent oral and written communication skills
• Strong interpersonal and negotiation skills
• Customer service oriented
• Ability to enable and drive change and continous improvement
• Able to work effectively in English
• Self-starter, able to schedule and progress workload on own
• Good time management skills, with ability to mulit-task and work under pressure
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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