Senior Associate QA Specialist - 12 Month FTC

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.

Brief Description:

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.

Essential Functions

Key Responsibilities / Accountabilities

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

Quality Vendor Management

New Supplier/Vendor onboarding

Internal and External Audit management

Detailed Responsibilities / Accountabilities

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

Management of quality qualifications and approval of vendor to ensure compliance to regulations.

Ensures vendors are maintained and monitored using a risk-based approach which links into the external auditing process and the business.

Lead and support internal and external audits, report write up and response management.

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

Required Knowledge, Skills, and Abilities

Skills:

Working knowledge of office IT packages

High level of written and verbal communication skills

Attributes and Behaviors:

Motivated individuals that have extensive experience across many disciplines within the pharmaceutical industry and have spent a significant period of time within quality assurance, demonstrating the ability to develop quality systems.

Required / Preferred Education and Licenses

Education:

Typically, Bachelor’s degree (or equivalent) in science or related discipline

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

Experience:

Extensive work experience in the Pharmaceutical, Biotechnology or a related industry

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

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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