Job Description
Cpl in partnership with our client Pfizer are seeking Senior Associate External Supply - Operations Quality, to join the team at their state of the art plant in Dublin, Grange Castle for a 12 month fixed term contract. This role has a hybrid working model. External Supply Operations Quality (ESOQ) is responsible for the Quality management of approximately 400 contract manufacturers, packagers, and supply partners globally. The Senior Associate will be responsible for supporting Contractor Quality Leads (CQL) and Team Leads in activities associated with the oversight of contract manufacturers who manufacture products for Pfizer. Responsibilities: The Associate will be responsible for activities, delegated by CQL, that support contract manufacturer oversight and product compliance, including but not limited to: Review and summarize Annual Product Review and Product Quality Review (APR/PQR) reports, notify the Contractor Quality Leads (CQLs) of any issues, and provide the summary for approval. Lead and Project Manage compliance and continuous improvement initiatives and projects. Support and execute tasks in the Quality Tracking System (QTS) and Supplier Management System (SMS) in support of product and contractor oversight. Review and track intercompany complaints and product temperature excursions.Support product compliance-related activities to allow proper supply, e.g. batch Certificate of Analysis related requests. Support the team in management of QTS commitments, complaints, change controls, etc. within quality systems as necessary. Provide support in management and presentations of team KPI metrics. Participate and support risk assessments related to contractors / products as necessary. Qualifications: Minimum. University degree in Science, Engineering, Pharmaceutical Sciences or similar. At least 3 years of Product Quality Assurance experience in a GMP environment. Aseptic manufacturing experience would be an asset. Experience with external suppliers/contractors is preferred. Advanced in computer skills such as MS Office applications and good knowledge of enterprise systems such as SAP, QTS Trackwise, Documentum platforms. Good command of English language and multi-lingual is a benefit. Strong verbal and written communication skills including presentation skills. Able to work in diverse multi-level, cross-divisional and multi-cultural global working environment. Able to report remotely and deliver work independently. Show strong negotiation skills and customer focus. Is diplomatic in communication with internal and external customers. Demonstrate ability to prioritize work, manage multiple projects, act and work independently and to report items as required to Team Leader. Take initiative and be proactive. Actively participate in Team Meetings by reporting activities, achievements and lessons learned. Skills: Annual Product Review Product Quality Review Product Quality Assurance SAP QTS Trackwise