QC Team Leader

7 days ago

Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time
QC Team Leader - Ireland - 12 Months Contract

Our client is one of the world's largest pharmaceutical organisations. With continued organisational growth including ongoing investment across the portfolio and capital projects programme at their manufacturing facility in Ireland, an excellent opportunity has arisen for a QC Team Leader to join the team.

Essential Duties and Responsibilities for this role include, but are not limited to, the following:
  1. Serve as point of contact for commercial product complaints and post market product vigilant monitoring processes.
  2. Receive, initiate, investigate and conclude product complaint investigations using the current product complaints management mailbox and software.
  3. Coordinate all aspects of investigation through to closure and/or provide oversight for complaint handling process.
  4. Apply departmental procedures to assess product complaints' impact on patient safety and product quality compliance.
  5. Assess product complaints and determine if escalation is required due to potential regulatory notification requirements.
  6. Interface and collaborate with various departments including the OpUs, External Supply, Quality Assurance, Regulatory, Development, Safety/Pharmacovigilance, etc. and the regional organisation. Interface with external stakeholders such as CMO, Call Centres and vendors/contractors on product complaint issues.
  7. Assure that all product complaints are investigated to the appropriate level within the required timeline.
Desirable Experience includes:
  1. Bachelor's degree with extensive experience in Quality Assurance or a GMP related field within Medical device, biotechnology or pharmaceutical manufacturing, or equivalent.
  2. Supervisory Experience in an analytical laboratory environment.
  3. Technical Knowledge of GC (Gas Chromatography) and HPLC (High Performance Liquid Chromatography) analysis.
  4. Experience with continuous improvement plans within the QC environment.
  5. Experience managing, motivating and leading a team of analysts.
  6. Working knowledge of cGMPs and other regulatory requirements governing combination drugs and device products.
  7. Knowledge of EU/ FDA cGMP requirements pertaining to drug/device product complaints reporting and investigation.
  8. Combination working experiences in product complaints handling, deviation management, CAPAs, quality compliance investigations, risk management, and cGMP audits.
  9. Good understanding of the manufacture of combination products and the linkage to customer complaints.

For more information on this position, please apply with a copy of your CV today

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