QC Team Leader
A dynamic opportunity has arisen for a QC Team Leader to join one of the world's largest pharmaceutical organisations in Ireland on a 12-month contract.
Key Responsibilities:
* Serve as the primary point of contact for commercial product complaints and post-market product vigilant monitoring processes.
* Receive, initiate, investigate, and conclude product complaint investigations using current product complaints management software.
* Coordinate all aspects of investigation through to closure and provide oversight for the complaint handling process.
* Apply departmental procedures to assess the impact of product complaints on patient safety and product quality compliance.
* Assess product complaints and determine if escalation is required due to potential regulatory notification requirements.
* Interface and collaborate with various departments, including Quality Assurance, Regulatory, Development, Safety/Pharmacovigilance, and external stakeholders such as CMOs, Call Centres, and vendors/contractors.
* Ensure that all product complaints are investigated to the appropriate level within the required timeline.
Desirable Experience:
* Bachelor's degree with extensive experience in Quality Assurance or a GMP-related field within Medical device, biotechnology, or pharmaceutical manufacturing, or equivalent.
* Supervisory experience in an analytical laboratory environment.
* Technical knowledge of GC (Gas Chromatography) and HPLC (High Performance Liquid Chromatography) analysis.
* Experience with continuous improvement plans within the QC environment.
* Experience managing, motivating, and leading a team of analysts.
* Working knowledge of cGMPs and other regulatory requirements governing combination drugs and device products.
* Knowledge of EU/FDA cGMP requirements pertaining to drug/device product complaints reporting and investigation.
* Combination working experiences in product complaints handling, deviation management, CAPAs, quality compliance investigations, risk management, and cGMP audits.
* Good understanding of the manufacture of combination products and the linkage to customer complaints.