OverviewGlaxoSmithKline QA Logistics & Distribution Manager Full Time in Mississauga, ON
Branch Mississauga ON CA
QA Logistics & Distribution Manager
Ensure Quality Assurance Agreement with Logistics Service providers, warehouses and distribution facilities are established/up to date and that comply with…
• Graduate in Chemistry, Pharmacy, Microbiology or another related science
• 3 years of Quality experience within the pharmaceutical industry, and application of Quality Systems
• Quality Compliance experience and application of Quality Systems and GMP/GDP within the pharmaceutical industry
• Problem identification and solving skills
• Good leadership skills
• Excellent oral and written communication skills in English
• Strong interpersonal and negotiation skills
• Ability to enable and drive change and continous improvement
• Ability to set clear directions
• Self-starter, able to schedule and progress workload on own GMP/GDP knowledge and problem solving skills due to the often complex and technical origin of product quality issues and events.
• Customer service oriented
Ensure oversight on Logistics related activities within the supply chain to ensure quality of GSK CH products during distribution. Ensure that operations performed by 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 assigned Logistics Service providers and monitor compliance through defined key performance and quality performance indicators.
Ensure risk associated with logistics operations are evaluated, communicated to the organization and actions to mitigate/avoid the identified risks are implemented.
Continuously improve, harmonize and establish QA and Compliance systems, strengthen quality awareness, implement the development of strategic plans, 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..
Work with the business partners to ensure that the QA 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.
Be Subject Matter Expert for GDP related topics and support both local, Divisional and Global QA organizations upon request and work with the GSK QA organization as a liaison between GSK and assigned third parties for any corporate or global initiatives regarding logistics and distribution.
Lead implementation of GSK CH Quality standards and GMP requirements within assigned Logistics Service providers and provide direction and support for all quality matters.
Perform surveillance on new/upcoming regulations related to Distribution and Logistics and highlight/anticipate actions needed to implement.
Provide direction and coaching for resolution of quality issues impacting logistic operations and ensure formal escalation process is followed.
Be the point of contact for all quality matters with assigned Logistics Service providers, warehousing and distribution facilities and inform markets as appropriate of any deviations, change controls, audit findings or complaints that may affect products sold in their market. In the event of a product recall assessment, ensure that a timely evaluation is performed with cross functional team as per procedure
Ensure that complaints, investigations, effective CAPAs and change controls associated with assigned Logistics Service providers, warehousing and distribution facilities are properly performed, documented, evaluated, and closed in a timely manner as per procedures.
Ensure appropriate compliance oversight of Logistics service providers, warehouses and distribution facilities is maintained through appropriate monitoring audits. Ensure appropriate supplier audit, approval and control processes are in place for vendors having an impact on product quality and distribution and within the remit of the LOC (repackers, art houses, destruction service providers, reverse logistics providers, documentation services, etc).
Ensure Quality Assurance Agreement with Logistics Service providers, warehouses and distribution facilities are established/up to date and that comply with GSK Quality Manual and GDP requirements.
• Perform routine checks on validity of local GDP/GMP Licenses held by all 3PLs and third party distributors.
Ensure the mandatory 3PL WMS to GSK ERP controls are in place and routinely verified as in place and in use.
Assist the audit team in audit preparation and participate in the audit execution of assigned warehousing and distribution facilities for both internal and regulatory agency inspections.
Ensure any commitments given to address audit observations (both GSK and Health Authority) by assigned third party Logistics Service providers are implemented as described in the agreed time frame. Ensure verification processes are in place, in use and robust.
Ensure participation in regular business review meetings and ensure quality topics, KPI’s, and concerns are raised and discussed with GSK and Logistics Service providers management and ensure periodic risk assessments are performed with a cross functional team per procedure
Ownership of Distribution Risk Assessment process for incoming and in-market product distribution activities, ensuring partnership with Operational Quality and CMO Quality groups to ensure DRA risks are identified, mitigated and monitored with linkages to the Quality Agreement/TTS documents.
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Employment Type: Full Time
Location: Mississauga, ON, CA
Posted on: 2015-08-18