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Quality Control Specialist

T-pro

Dublin

On-site

EUR 65,000 - 72,000

Full time

30+ days ago

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Job summary

A leading pharmaceutical company in Dublin is seeking a Quality Assurance Specialist to enhance client experiences through effective Quality Control processes. This position involves developing QC requirements, adhering to GMP standards, and ensuring collaboration across teams, providing an exciting opportunity to impact critical medicine production.

Qualifications

Minimum 2 years experience in QC operations within a Pharma environment.
Ability to perform QC activities in a cGMP setting.
Demonstrated capability in cross-functional team operations.

Responsibilities

Develop Quality Control requirements for GMP operations.
Ensure compliance with GMP/GLP standards.
Collaborate and communicate effectively with team members.

Skills

Problem Solving

Organisational Skills

Collaboration

Education

Primary Degree in scientific discipline or equivalent

Relevant post-graduate qualification

Tools

LIMS

LabX

UV software

About VLE Therapeutics

with a local supply chain for these critical medicines.

To create the best client experience, we are creating and & implementing a seamless handover process from APC process development into GMP manufacturing, leveraging our novel platforms to deliver as a Medicine Accelerator. This is a unique opportunity for the successful candidate to become involved in ATMP and related pharmaceutical developments.

Ownership to develop the Quality Control requirements for VLE GMP manufacturing operations, including testing requirements, sampling plans, engagement with outsource QC suppliers.
Execution of process, environmental and facilities monitoring, sampling, and testing is completed in line with GMP manufacturing needs.
Develop and execute required documentation to support QC (SOP’s, Test methods, sampling plans, CoA’s, LIR, Protocols, Reports) and completion of required analytical data review.
Provide laboratory support across the organisation through collaboration with scientists and engineers, both internally and externally, ensuring GMP/GLP standards are maintained at all times.
Collaborate with the VLE team members at relevant meetings and proactively communicate with the team members and/or departments on issues.
Support investigation of analytical failures or out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools and to implement effective corrective and preventative actions while ensuring all investigations are closed with the specified lead-time.
Development & ongoing evaluation of analytical training programme and the training of any new laboratory personnel.
Assist with project management of VLE analytical activities and proactively identify & implement improvement projects.
Set up, proper use and maintenance of relevant analytical equipment and systems (e.g., LIMS/LabX/UV software)
Assist with laboratory 6S and maintain good housekeeping.

Essential

QC Operations professional with GMP Pharma experience (minimum 2 years' experience.
Ability to performing QC activities in a cGMP manufacturing environment)
Primary Degree in scientific discipline or equivalent
Demonstrated ability to operate within cross-functional teams
Effective organisational skills and ability to self-direct

About VLE Therapeutics

Powered by transformation research in APC, VLE Therapeutics Ltd was formed to extend the value chain and deliver science and digital led manufacturing of Vaccines and Advanced Therapeutics. VLE Therapeutics will support GMP clinical manufacturing of advanced therapeutics and aims to transform the time and cost associated to produce medicines for our clients. This will be the first Irish-owned facility expressly designed to provide Ireland and Europe with a local supply chain for these critical medicines.

To create the best client experience, we are creating and & implementing a seamless handover process from APC process development into GMP manufacturing, leveraging our novel platforms to deliver as a Medicine Accelerator. This is a unique opportunity for the successful candidate to become involved in ATMP and related pharmaceutical developments.

The work we dois unique and our coexistence with APC on our campus gives us incredible opportunities to learn from and collaborate with,our APC colleagues, technically and personally in a shared modern and exciting cultural environment which makes VLE Therapeuticsa great place to work.

Principal Responsibilities

Ownership to develop the Quality Control requirements for VLE GMP manufacturing operations, including testing requirements, sampling plans, engagement with outsource QC suppliers.
Execution of process, environmental and facilities monitoring, sampling, and testing is completed in line with GMP manufacturing needs.
Develop and execute required documentation to support QC (SOP’s, Test methods, sampling plans, CoA’s, LIR, Protocols, Reports) and completion of required analytical data review.
Provide laboratory support across the organisation through collaboration with scientists and engineers, both internally and externally, ensuring GMP/GLP standards are maintained at all times.
Collaborate with the VLE team members at relevant meetings and proactively communicate with the team members and/or departments on issues.
Support investigation of analytical failures or out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools and to implement effective corrective and preventative actions while ensuring all investigations are closed with the specified lead-time.
Development & ongoing evaluation of analytical training programme and the training of any new laboratory personnel.
Assist with project management of VLE analytical activities and proactively identify & implement improvement projects.
Set up, proper use and maintenance of relevant analytical equipment and systems (e.g., LIMS/LabX/UV software)
Assist with laboratory 6S and maintain good housekeeping.

Essential

Experience & Qualifications

QC Operations professional with GMP Pharma experience (minimum 2 years' experience.
Ability to performing QC activities in a cGMP manufacturing environment)
Primary Degree in scientific discipline or equivalent
Relevant post-graduate qualification an advantage
Demonstrated ability to operate within cross-functional teams
Effective organisational skills and ability to self-direct

How To Apply

Suitable applicants should submit a CV and Cover Letter. Please note that the closing date for applications for this position is31st May 2025.

VLE is committed to the principle of equal opportunity for all employees.All employment decisions at VLE are based on business needs, job requirements and individual qualifications, without regard to gender, ethnicity, age, religious belief, disability, sexual orientation, gender identity and/or expression, marital status, or any other status protected by Irish law.

Salary

Negotiable

Seniority level

Seniority level
Not Applicable

Employment type

Employment type
Full-time

Job function

Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing

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