Product Quality Complaints Specialist
|Job Title:||Product Quality Complaints Specialist|
|Contact Name:||Laurentina Kennedy|
|Job Published:||12 months ago|
QA Product Quality Surveillance Specialist will work closely and collaboratively with the Product Quality Management Leads, Technical Operations and other functions/stakeholders across the Business to execute product quality surveillance strategies specifically Product Quality Complaint administration. This includes Product Quality Complaints, Product Quality Review / Annual Product Review, Product Recall, Incident Management, and support for the integration of new product acquisitions into post-marketing product quality surveillance.
Actively involved in daily operations and coordination to meet schedules and resolve issues. Escalates to management when challenges occur. Actively involved in the resolution of complex problems.
Post Marketing Product Quality Surveillance:
Provide support to delivery, drive and maintain effective Product Quality Surveillance systems including
Effective global Product Quality Complaint Handling
Effective global Product Annual / Periodic Product Quality Review
Effective global Product Recall Management
Support the provision of metrics regarding key performance indicators of quality from Product Quality Surveillance System in support of the company and their Suppliers
Process global commercial/clinical product Quality Complaints received
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
Critical evaluation of Customer Report complaints about serious cGMP and Device/ Combination product violations.
Assists with investigations on higher risk complaints, such as those that may or have led to Regulatory /Field actions. Lead investigation meetings as needed.
Performs Management review and final closure in TrackWise of Patient Inquires, Partner Notifications and Customer Report Complaints. Escalates potential Regulatory /Field actions to management.
Point of contact for International colleagues and LOC contacts and provides guidance to global partners.
Liaise with International Quality and global PQS Staff to ensure intake of appropriately redacted international complaint data is received, assessed and processed and escalates potential issues/ incidents to management, including but not limited to Field alerts, PDRs, BPDRs, MDRs or possible recall situations are escalated appropriately
Assign actions related to each PQC investigation and work with the appropriate Technical and Quality personnel to drive timely delivery of these actions
Perform trend analysis on all incoming PQCs escalating to incidents and potential risks to management.
Primary Contact for Pharmacovigilance for the reconciliation of AEs and Complaints. Assesses Complaints about reportability and categorisation. Communicate adverse events reported in conjunction with PQCs to PVRM.
Facilitate complaint sample returns (from consumer, pharmacy, healthcare provider or distributor) for inspection investigation.
Coordinate pharmacy credits for a returned product through Customer service.
Coordinate process and review PQC investigations performed at contract site manufacturer packagers and site investigations in conjunction with Quality Assurance.
Evaluate PQC investigation results to ensure adherence to cGMP guidelines and expectations (including device and Combination product cGDPs) in conjunction with technical and quality SMEs as appropriate.
Generate final correspondence summarising investigational findings and communicate via letter or fax to complainant or communicate via the relevant international QA to ensure local communication requirements are met.
Contact Training for the lead of PQC team and external partners. Participate in third-party call monitoring to ensure correct communication strategies are being utilised.
Subject Matter Expert and primary contact for TrackWise Complaint process.
Identifies system changes and enhancements.
Initiates and drives system changes to the implementation.
Assigns and conducts training to new employees on PQC processes
Perform Trend and Key Performance Indicator Analysis
Conducts in-depth analysis of complaint trends. Evaluates trending data and selects methods for in-depth analysis based on data and results.
Responsible for completing complaint trending for the Annual Product Review and authoring Complaint section summaries.
Develops and implements actions associated with product quality complaints and trends are appropriately assigned and implemented.
Compiles and communicates product quality complaint performance measures and Product Complaint Quality Management system measures and associated action plans to Management.
Review and Confirm Compliance Index reports for accuracy.
Acquisition & Integration Support:
Support and facilitate delivery of products entering the in-line supply chain into Quality Systems, including; APQR, Product Compliant System, and Product Management and monitoring programs such as Critical Process Verification and monitoring.
Lead implementation of TrackWise Complaint workflow changes as TrackWise SME.
Regulatory Awareness, Inspection support and Compliance
Primary Contact for generation of reports for management and inspections as required.
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.
Primary backup to management in support of regulatory inspections regarding products and post-marketing product surveillance activities.
Primary backup to management in support of regulatory notification or market correction activities (i.e. field alert and recall activities)
Initiate, author, revise or assist in the review of SOPs, and other cGMP documentation including to CAPA, Deviation, etc)
Education & Experience Requirements
MS or Bachelor's degree in a relevant scientific/engineering discipline with at least 8 years GMP industry experience, the majority of which has been gained in the QA environment and includes manufacturing related experience.
The Quality Assurance Specialist -Product Quality Surveillance 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.
Strong working knowledge of electronic data management systems (e.g. TrackWise and Master Control)
Strong working knowledge of Microsoft Office applications (e.g. Word, Excel, PowerPoint)
For further information on this Product Quality Technical Complaints Specialist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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