Senior Associate Quality Assurance Specialist (12 Month Fixed Term Contract)

If you are a current Jazz employee please apply via the Internal Career site.

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit

for more information.

About the Role:

To assist the Quality Compliance Manager and other QA team members in the implementation of the Quality Systems at the KSP facility and associated contractor sites.

Key Responsibilities

Managing and maintaining of the quality management system:

Corrective and preventative actions (CAPA)

Deviations

Change control

Supplier and customer complaints

Quality risk management (QRM)

Leading root cause analysis (RCA)

Liaising with global process owners to ensure consistency in the QMS between sites and functions

Training in the QMS

Collating QMS metrics and KPI data

Presenting QMS data at quality management review (QMR) meetings

Detailed Responsibilities:

Prepares, reviews, updates and completes QMS processes

Ensures training records are kept up to date

Carries out their work in a way that will not adversely affect their own, or others’ health, safety and security or the environment and reports any shortcomings in GW arrangements

Ensure all complaints are documented, investigated and closed out within agreed guidelines. That issues are escalated as required

Strives to ensure quality events are closed within agreed timeframes and facilitates management of quality events across KSP

Assisting in the assembly of the product quality review

Ensuring that regulatory, marketing partners due diligence and other audit/inspections performed at GW are supported with efficient document retrieval and supply of the technical information

Assist in the creation of technical agreements, supplier agreements and quality risk assessments

Participate or leads projects to deliver improvements in productivity and efficiency in all areas relevant to complaints

Authors and reviews all required quality documents

Creates training packages for QMS process at KSP

Authors and edits SOPs associated with the QMS at KSP

Essential Skills:

Knowledge:

Typically, Bachelor’s degree in science or related discipline

Post-graduate qualifications (Master’s, PhD) preferred

Experience

Minimum 3 years relevant work experience in the Pharmaceutical, Biotechnology or a related industry

Experience working within a quality environment, including experience in GMP, GACP and GDP

Skills

Working knowledge of office IT packages

High level of written and verbal communication skills

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here