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• Provide support to delivery, drive and maintain effective Product Quality Surveillance systems including but not limited to:
o Effective global Product Quality Compliant Handling o Effective global Product Annual / Periodic Product Quality Review o Effective global Product Recall Management o Support the provision of metrics regarding key performance indicators of quality from Product Quality Surveillance System in support of Suppliers
Specifically the Complaint Specialist shall:
• Process global commercial / clinical product Quality Complaints received o Assess incoming Product Quality Complaints (PQC) elevating potential issues/ incidents to management, including but not limited to Field alerts, PDRs, BPDRs, MDRs or possible recall situations o Liaise with International Quality to ensure intake of appropriately redacted international complaint data is received assessed and processed and potential issues/ incidents to management, including but not limited to Field alerts, PDRs, BPDRs, MDRs or possible recall situations are escalated appropriately o Assign actions related to each PQC investigation and work with the appropriate Technical and Quality personnel to drive timely delivery of these actions o Perform trend analysis on all incoming PQCs escalating to incidents and potential risks to management o Communicate adverse events reported in conjunction with PQCs to PVRM o Facilitate complaint sample returns (from consumer, pharmacy, healthcare provider or distributor)for inspection / investigation o Coordinate pharmacy credits for returned product through Customer service o Coordinate process and review PQC investigations performed at contract site manufacturer / packagers and Shire site investigations in conjunction with Quality Assurance o Evaluate PQC investigation results to ensure adherence to cGMP guidelines and expectations (including device and Combination product cGMPs) in conjunction with technical and quality SMEs as appropriate o Generate final correspondence summarizing investigational findings and communicate via letter or fax to complainant / or communicate via the relevant international QA to ensure local communication requirements are met. o Generate reports for management and inspections as required o Assist as needed in the preparation of data for internal audits and external audits / inspections o Participate in third party call monitoring to ensure correct communication strategies are being utilized. o Assist as needed in preparation and evaluation of complaint summary and trend reports 10% Acquisition & Integration Support: • Support and facilitate delivery of products entering the in-line supply chain into Quality Systems, including but not limited to; APQR, Product Compliant System, and Product Management and monitoring programs such as Critical Process Verification and monitoring. 5% Regulatory Awareness, Inspection support and Compliance • Maintain awareness of MHRA/HPRA/EMA/FDA/DEA, etc. regulatory actions that may affect products. • Supports regulatory reporting and submissions as applicable. • Keep informed of all regulatory changes, rulings and current industry practices concerning Post Marketing Surveillance activities. • When appropriate, assist in regulatory inspections regarding products and post marketing product surveillance activities. • When appropriate, assist in regulatory notification or market correction activities (i.e. field alert / recall activities) • Initiate, author, revise or assist in the review of SOPs, and other cGMP documentation including but not limited to CAPA, Deviation, etc)
• MS or Bachelor’s degree in a relevant scientific/engineering discipline with at least 5 years GMP industry experience, the majority of which has been gained in the QA environment and includes manufacturing related experience. • The Senior Specialist will be strong scientifically with technical expertise to ensure robust analysis of complex product data and the ability to assess that information to make scientifically sound quality risk based recommendations. • Working knowledge of Regulations, US and EU Regulations, including cGMPs, and GDPs, including knowledge of Controlled substance standards accommodating for example, DEA, IMB, UK Home Office etc.