Application deadline:
03/12/2025
Location:
Cork T45 RP82, Ireland, Ireland
Contract type:
Permanent
Job ID:
****
LEO Pharma are currently recruiting an experienced Quality Specialist to join our talented team in Cork
At LEO Pharma, we are global leaders in medical dermatology.
We have 115 years' experience in bringing innovation to healthcare.
And we are eager to do much more.
Each year, close to 100 million people have a better day because of our medicines.
Our facility in Cork is uniquely positioned to make a significant difference for patients.
We focus on high-risk patient groups and supporting healthcare systems with high quality medicines with critical-care conditions.
In the Quality Management team, we share a "challenge accepted" mindset and are guided by our winning behaviours of simplification, collaboration, and accountability, to achieve our goals.
Your Role
As our new
Quality Specialist
, you will certify drug substances for release, ensuring compliance with cGMP and product licences.
You will also manage approval of deviations, CAPA, change controls, and lab investigations, and provide quality support and drive quality improvement across API Manufacturing.
Your Responsibilities
Conducting batch release in line with cGMP and internal QA systems.
Reviewing and approving quality documentation, SOPs, work instructions, and testing methods.
Overseeing and ensuring compliance within regulations, and LEO QMS.
Preparing annual Product Quality Reviews (PQRs)
Supporting regulatory submissions and audits (internal, customer and regulatory).
Investigating quality complaints and ensuring timely resolution.
Leading and participating in quality improvement and global projects.
Coordinating with internal teams and external partners
Providing GMP training and managing GMP documentation processes.
Driving continuous improvement initiatives.
Please note:
This role requires attendance on-site in Cork, five days per week for the initial training period of 8-12 weeks, reducing to four days per week on-site, with one day per week working remotely once completed.
Your Qualifications
Bachelor's Degree or higher, in Chemistry, Pharmaceutical Science or Biotechnology, or equivalent by experience.
Knowledge of Good Manufacturing Practice (GMP), Quality Management Systems (QMS), and Regulatory Compliance.
Additional certifications in Quality Assurance, Lean Six Sigma, or Risk Management are advantageous.
Significant experience in pharmaceutical manufacturing, ideally in API production or similar GMP-regulated environments.
Solid understanding of pharmaceutical production processes, QC laboratory operations, and global regulatory standards with demonstrated experience in batch release of pharmaceutical products.
Experience of quality systems including CAPA, Change Control, SOP management, deviation handling, and effectiveness checks.
Experience of root cause analysis and problem-solving in regulated environments.
Preparation and participation in audits (regulatory authority and customer) is required.
Experience with documentation systems such as Veeva Vault, LIMS and ERP.
Familiarity with regulatory submissions and Annual Product Quality Reviews (PQR).
Skilled in cross-functional collaboration and communication across departments and locations.
Ability to lead or participate in global quality improvement initiatives and projects.Top of Form
This is an exciting opportunity to further develop your quality management skills, take on responsibilities, and contribute to a welcoming and team-orientated pharmaceutical manufacturing environment.Top of Form
LEO Pharma is built on collaboration, innovation and curiosity.
Is this you?
Can you bring this, LEAN and Six Sigma philosophy and excellent attention to detail with a quality focus mindset?
Your Application
You do not need to upload a cover letter, but feel free to add a few sentences in your CV on why this position has your interest.
Please refrain from including a photograph.
Beyond the skin
Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact.
Our innovative approach sets us apart.
We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet.
At LEO Pharma, we believe in the power of individuals to drive change.
Our flat organizational structure empowers you to make a visible impact and offers versatile roles for professional growth.
We value diversity and welcome applications from all qualified candidates, recognizing that our different perspectives, backgrounds, and attitudes enable us to make the best decisions.
Join our passionate team at LEO Pharma and be yourself as we work together to make a difference.
For certain positions, LEO Pharma might complete a background check conducted by a third party.
Join us on our journey Beyond the Skin.
Apply today
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