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Quality Control Manager

Univet Limited -
Cootehill, County Cavan

Apply Now

Job details

Permanent | Full-time
14 days ago

Qualifications

Continuous improvement
Quality control
Organisational skills
Chemistry
Quality systems
Manufacturing
Leadership
Communication skills

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

Investigation Management

Lead and technically review investigations including:

Out of Specification (OOS)
Out of Trend (OOT)
Laboratory Deviations
CAPAs
Change Controls
Laboratory Error Investigations

Responsibilities include:

Root Cause Analysis
Identification of Corrective and Preventive Actions
Risk Assessment
Effectiveness Checks
Presentation of investigation outcomes to senior management

Regulatory Compliance

Maintain laboratory compliance with:

EU GMP
Veterinary GMP
VICH Guidelines
Pharmacopoeial Requirements
HPRA
EMA
FDA (desirable)

Support:

Regulatory inspections
Customer audits
Internal audits
Supplier audits where required

Act as laboratory subject matter expert during inspections.

Continuous Improvement

Identify opportunities to improve:

Laboratory productivity
Turnaround times
Testing efficiency
Documentation quality
Right-first-time performance
Laboratory workflow
Automation opportunities

Champion Lean principles and continuous improvement initiatives.

Cross-Functional Collaboration

Work closely with:

Quality Assurance
Manufacturing
Engineering
Regulatory Affairs
Supply Chain
Validation
Technical Services

Provide scientific support for manufacturing investigations and product quality issues.

Commercial Awareness

Balance laboratory performance with business needs by:

Supporting on-time product release
Managing laboratory resources efficiently
Understanding manufacturing priorities
Controlling laboratory expenditure
Supporting strategic business objectives

Always ensuring that quality, regulatory compliance and patient safety are never compromised.

Essential Qualifications

Degree in Chemistry, Pharmaceutical Sciences, Analytical Chemistry or related scientific discipline.
Minimum 10 years’ experience within a GMP pharmaceutical Quality Control laboratory.
Minimum 5 years in a laboratory leadership or management role.
Experience within veterinary pharmaceuticals is highly desirable.

Essential Experience

Minimum 10 years GMP laboratory experience.
Extensive experience with Empower 3.
Strong HPLC troubleshooting expertise.
Experience managing electronic laboratory documentation.
Proven experience leading regulatory inspections.
Extensive experience managing OOS and laboratory investigations.
Experience reviewing analytical data.
Experience with method validation and transfer.
Strong understanding of Data Integrity.
Experience managing laboratory KPIs.
Experience leading teams through organisational change.
Experience implementing continuous improvement initiatives.

Technical Knowledge

Strong knowledge of:

EU GMP
Annex 11
Annex 15
Data Integrity Guidance
ALCOA+
Pharmacopoeial testing
Analytical Method Validation
Instrument Qualification
Stability Programmes
Laboratory investigations
CAPA systems
Risk Management (ICH Q9)

Personal Attributes

The successful candidate will demonstrate:

Excellent leadership and people management skills.
Strong scientific and analytical thinking.
Exceptional attention to detail.
High levels of integrity and professionalism.
Excellent communication skills.
Ability to make balanced, risk-based decisions.
Strong organisational skills.
Commercial awareness with a pragmatic approach.
A collaborative leadership style.
The ability to remain calm under pressure.
A commitment to continuous improvement.

Key Competencies

Leadership
Decision Making
Scientific Judgement
Problem Solving
Investigation Management
Regulatory Compliance
Customer Focus
Commercial Awareness
Planning & Organisation
Continuous Improvement
Communication
Team Development
Data Integrity
Quality Mindset

Success Measures

The successful QC Manager will be expected to deliver:

Right First Time laboratory performance.
Timely completion of analytical testing.
Robust and scientifically sound investigations.
Successful regulatory inspections.
High laboratory compliance standards.
Reduced laboratory turnaround times.
Continuous improvement in laboratory efficiency.
Strong team engagement and development.
Excellent cross-functional collaboration.
Consistent support of manufacturing while maintaining uncompromising quality standards.

Reports To: Head of Quality / Quality Director / Qualified Person

Apply Now

Refine Your Search

laboratory manager & business development jobs

Quality Control Manager

Area Sales Manager

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Senior Engineering Manager

Senior Manufacturing Manager

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QC In Process People Team Leader

Technical Specialist

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Global Technical Manager – Sterilization

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