Full job description

• Tullyvin, Cootehill, County Cavan,
• Negotiable
• Permanent | Full Time
• Contact name: Univet

Position Summary

The Quality Control (QC) Manager is responsible for leading the Quality Control function to ensure all testing activities support the manufacture and release of high-quality veterinary medicinal products in compliance with GMP, pharmacopoeial requirements and regulatory expectations.

The successful candidate will provide technical leadership to the laboratory, ensuring efficient laboratory operations while maintaining the highest standards of data integrity, scientific excellence and regulatory compliance. They will drive continuous improvement, support regulatory inspections, manage laboratory investigations, and foster a culture where quality and patient safety remain the highest priorities.

Key Responsibilities

Laboratory Leadership

• Lead and develop the QC team to achieve departmental objectives.
• Provide coaching, mentoring and performance management for laboratory personnel.
• Ensure laboratory resources are effectively allocated to meet manufacturing schedules.
• Promote a culture of accountability, ownership and continuous improvement.
• Develop succession planning and staff competency programmes.

Laboratory Operations

• Oversee all chemical and analytical testing including:
  • Raw Materials
  • Packaging Components
  • In-Process Samples
  • Finished Products
  • Stability Samples
  • Environmental Monitoring support where applicable
• Ensure laboratory testing is completed accurately and within agreed timelines.
• Drive laboratory efficiency without compromising product quality or regulatory compliance.
• Monitor KPIs and laboratory performance metrics.

Analytical Expertise

Demonstrate extensive experience in analytical techniques including:

• HPLC
• UPLC
• UV Spectroscopy
• FTIR
• Dissolution
• Karl Fischer
• pH
• Physical testing
• Pharmacopoeial methods

Provide scientific oversight for:

• Method troubleshooting
• Method validation
• Method transfer
• Method verification
• Instrument qualification

Electronic Quality Systems

Extensive experience using electronic quality systems including:

• Empower 3 Chromatography Data System
• Electronic Laboratory Documentation
• LIMS (desirable)
• Electronic Quality Management Systems (QMS)
• Data Integrity principles (ALCOA+)

Ensure all electronic records comply with:

• EU GMP Annex 11
• 21 CFR Part 11
• Data Integrity Guidance
• Company procedures