The Product Quality Surveillance Specialist – Commercial Complaints is an experienced Quality and Technical professional who delivers the Product Quality Surveillance activities for Client’s pipe-line products and appropriate support for in-line products to enable a sustainable existence on the market.
·Product Quality Surveillance Specialist works closely and collaboratively with the Product Quality Management Leads, Technical Operations and other Client functions / stakeholders across the Business to execute product quality surveillance strategies specifically Product Quality Complaint administration. This includes, but is limited to 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.
Essential Functions
Post Marketing Product Quality Surveillance:
•Provide support to delivery, drive and maintain effective Product Quality Surveillance systems including but not limited to:
Specifically the Complaint Specialist shall:
•Process global commercial / clinical product Quality Complaints received
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 Client’s 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 Client 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 Client cGMP documentation including but not limited to CAPA, Deviation, etc)
Integrated Resources INC
https://careers.smartrecruiters.com/IntegratedResourcesINC