Site Name: USA - California - Fresno
Posted Date: Mar 5 2020
As a Distribution Quality Specialist you will be responsible for providing effective and efficient support to the Local Operating Company (LOC) Quality Manager to maintain effective Quality Management System (QMS) and perform LOC Quality Operation activities in compliance with GSK Policies, QMS and local regulations.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Provide Quality support on Logistics and Display and Packaging related activities within the supply chain to assure quality of GSK CH 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 CH 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.
Assist Quality Logistics & Distribution Manager in the implementation of GSK CH 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 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.
We are looking for professionals with these required skills to achieve our goals:
If you have the following characteristics, it would be a plus:
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 continuous improvement
Able to work effectively in English
Self-starter, able to schedule and progress workload on own
Good time management skills, with ability to multi-task and work under pressure
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Continuously looking for opportunities to learn, build skills and share learning.
Sustaining energy and well-being.
Building strong relationships and collaboration, honest and open conversations.
Budgeting and cost-consciousness.
This is a job description to aide in the job posting, but does not include all job evaluation details.
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