Overview
Senior Quality Assurance Specialist/Drug Substance/Remote/Home Based Jobs in Dublin, Ohio, USA at Jazz Pharmaceuticals
Position: Senior Quality Assurance Specialist (Drug Substance) (Remote/Home Based)
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. The Biologics Drug Substance
Quality Assurance
Specialist is Responsible for performing key Quality tasks in
respect
of Company products.
Work in the External Manufacturing Quality Group within the Technical Operations department, which oversees contract manufacturing operations, as well as Internal Quality Systems. Reporting directly to the Associate Director of External Manufacturing
Quality Assurance
The position is responsible for monitoring and supporting the quality performance of contract manufacturing organizations and material suppliers to all applicable GXP standards. Monitoring the daily operations at the Contract Manufacturer, performing batch review and disposition, reviewing and approving product complaints, deviations, Validation protocols, change controls and leading product related investigations.
Ensuring compliance of all respective contract manufacturers to both internal Jazz requirements and country specific regulations
Collaboration
with all contract manufacturers, packagers and testing laboratories to resolve any quality issues.
Contributing to the successful outcome of all regulatory inspections associated with company business, both internally and at contract manufacturers, as required.
Highlighting any risks associated with maintaining supply of commercial drug products to all markets.
Assisting in internal audits and regulatory agency inspections.
Summarizing CMO Annual Product Quality Reviews and supporting regulatory submissions
Assist with the generation of Jazz APQR (Annual Product Quality Review).
Maintaining product related Quality Technical Agreements (QTAs).
Review and approve less complex validation documents.
Support delivery of projects.
Work with management to resolve project issues and resource constraints within the team.
Review and approve less complex validation documents.
Collaborate in the
continuous improvement
of the QA processes, identifying opportunities and leading them up to the implementation.
Represent QA in cross-functional project teams for moderately difficult projects.
Participate in and facilitate regulatory inspection readiness. Use the red Application button below to Read More / Continue the application process.
Title: Senior Quality Assurance Specialist/Drug Substance/Remote/Home Based
Company: Jazz Pharmaceuticals
Location: Dublin, Ohio, USA
Category: Quality Assurance – QA/QC
