Quality Control Specialist

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 do is 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 Therapeutics a 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.

Experience & Qualifications

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
• 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 is 31st 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