Job Title

Quality Analyst

Requisition

JR000015736 Quality Analyst (Open)

Location

College Park, Dublin - IRL006

Additional Locations

Job Description Summary

Quality Assurance Specialist

Job Description

Batch Review
- Preparation of CMO documentation for batch review.
- Review of batch records, addressing discrepancies and escalating where required to management.
- Preparation of disposition and release certification for reviewed batch records.
CMO Governance
- Management and oversight of third party supplier activities relating to the manufacture, packaging and testing of product.
- Regular telephone and email communication with CMOs to ensure timely manufacture and resolution of quality issues for product.
- Continuous monitoring of product and performance from CMOs.
Quality Support and Deputation
- Monitoring cold-chain transportation, for both qualification and routine
- CMO Maintenance
- Input into Technical Quality Agreements
- Post-launch support for quality activities in various countries
- Management of delegated projects
Audits
- Drive the audit readiness programme to ensure audit compliance at all times.
Quality/QMS Projects
- As required.

Minimum Requirements

Education / Experience / Skills:

Bachelor’s Degree in scientific discipline, preferred +3-5years’ experience working as QA Specialist
Direct experience working with Quality Systems (deviations, change controls, training, supplier qualification and document management systems)
Knowledge of cGMP requirements for pharmaceutical manufacturing and knowledge of GDP and ISO 13485

Competencies:

Good interpersonal skills; ability to communicate well, both verbally and written
Able to function effectively in teamwork environment
Demonstrate ability to work independently
Thorough, diligent and good attention to detail
Collaborator with strong levels of engagement with individuals and team
High level of delivery and work completion
Strong organisational skills

At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support—showing up in big moments and small to help patients find comfort and confidence.

We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.

We are Keenova—keen to solve, keen to serve. Learn more at www.keenova.com.