Univet Ltd.
Advance your career
- 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
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Lead and develop the QC team to achieve departmental objectives.
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Provide coaching, mentoring and performance management for laboratory personnel.
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Ensure laboratory resources are effectively allocated to meet manufacturing schedules.
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Promote a culture of accountability, ownership and continuous improvement.
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Develop succession planning and staff competency programmes.
Laboratory Operations
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Oversee all chemical and analytical testing including:
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Raw Materials
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Packaging Components
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In-Process Samples
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Finished Products
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Stability Samples
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Environmental Monitoring support where applicable
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Ensure laboratory testing is completed accurately and within agreed timelines.
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Drive laboratory efficiency without compromising product quality or regulatory compliance.
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Monitor KPIs and laboratory performance metrics.
Analytical Expertise
Demonstrate extensive experience in analytical techniques including:
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HPLC
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UPLC
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UV Spectroscopy
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FTIR
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Dissolution
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Karl Fischer
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pH
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Physical testing
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Pharmacopoeial methods
Provide scientific oversight for:
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Method troubleshooting
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Method validation
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Method transfer
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Method verification
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Instrument qualification
Electronic Quality Systems
Extensive experience using electronic quality systems including:
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Empower 3 Chromatography Data System
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Electronic Laboratory Documentation
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LIMS (desirable)
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Electronic Quality Management Systems (QMS)
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Data Integrity principles (ALCOA+)
Ensure all electronic records comply with:
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EU GMP Annex 11
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21 CFR Part 11
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Data Integrity Guidance
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Company procedures
Investigation Management
Lead and technically review investigations including:
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Out of Specification (OOS)
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Out of Trend (OOT)
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Laboratory Deviations
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CAPAs
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Change Controls
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Laboratory Error Investigations
Responsibilities include:
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Root Cause Analysis
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Identification of Corrective and Preventive Actions
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Risk Assessment
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Effectiveness Checks
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Presentation of investigation outcomes to senior management
Regulatory Compliance
Maintain laboratory compliance with:
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EU GMP
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Veterinary GMP
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VICH Guidelines
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Pharmacopoeial Requirements
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HPRA
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EMA
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FDA (desirable)
Support:
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Regulatory inspections
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Customer audits
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Internal audits
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Supplier audits where required
Act as laboratory subject matter expert during inspections.
Continuous Improvement
Identify opportunities to improve:
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Laboratory productivity
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Turnaround times
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Testing efficiency
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Documentation quality
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Right-first-time performance
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Laboratory workflow
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Automation opportunities
Champion Lean principles and continuous improvement initiatives.
Cross-Functional Collaboration
Work closely with:
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Quality Assurance
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Manufacturing
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Engineering
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Regulatory Affairs
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Supply Chain
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Validation
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Technical Services
Provide scientific support for manufacturing investigations and product quality issues.
Commercial Awareness
Balance laboratory performance with business needs by:
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Supporting on-time product release
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Managing laboratory resources efficiently
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Understanding manufacturing priorities
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Controlling laboratory expenditure
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Supporting strategic business objectives
Always ensuring that quality, regulatory compliance and patient safety are never compromised.
Essential Qualifications
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Degree in Chemistry, Pharmaceutical Sciences, Analytical Chemistry or related scientific discipline.
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Minimum 10 years’ experience within a GMP pharmaceutical Quality Control laboratory.
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Minimum 5 years in a laboratory leadership or management role.
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Experience within veterinary pharmaceuticals is highly desirable.
Essential Experience
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Minimum 10 years GMP laboratory experience.
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Extensive experience with Empower 3.
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Strong HPLC troubleshooting expertise.
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Experience managing electronic laboratory documentation.
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Proven experience leading regulatory inspections.
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Extensive experience managing OOS and laboratory investigations.
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Experience reviewing analytical data.
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Experience with method validation and transfer.
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Strong understanding of Data Integrity.
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Experience managing laboratory KPIs.
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Experience leading teams through organisational change.
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Experience implementing continuous improvement initiatives.
Technical Knowledge
Strong knowledge of:
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EU GMP
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Annex 11
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Annex 15
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Data Integrity Guidance
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ALCOA+
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Pharmacopoeial testing
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Analytical Method Validation
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Instrument Qualification
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Stability Programmes
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Laboratory investigations
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CAPA systems
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Risk Management (ICH Q9)
Personal Attributes
The successful candidate will demonstrate:
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Excellent leadership and people management skills.
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Strong scientific and analytical thinking.
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Exceptional attention to detail.
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High levels of integrity and professionalism.
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Excellent communication skills.
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Ability to make balanced, risk-based decisions.
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Strong organisational skills.
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Commercial awareness with a pragmatic approach.
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A collaborative leadership style.
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The ability to remain calm under pressure.
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A commitment to continuous improvement.
Key Competencies
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Leadership
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Decision Making
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Scientific Judgement
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Problem Solving
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Investigation Management
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Regulatory Compliance
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Customer Focus
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Commercial Awareness
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Planning & Organisation
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Continuous Improvement
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Communication
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Team Development
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Data Integrity
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Quality Mindset
Success Measures
The successful QC Manager will be expected to deliver:
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Right First Time laboratory performance.
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Timely completion of analytical testing.
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Robust and scientifically sound investigations.
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Successful regulatory inspections.
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High laboratory compliance standards.
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Reduced laboratory turnaround times.
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Continuous improvement in laboratory efficiency.
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Strong team engagement and development.
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Excellent cross-functional collaboration.
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Consistent support of manufacturing while maintaining uncompromising quality standards.
Reports To: Head of Quality / Quality Director / Qualified Person