If you are a current Jazz employee please apply via the Internal Career site.
Do you have the following skills, experience and drive to succeed in this role Find out below.
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
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. xxuwjjq
Required / Preferred Education and Licenses
Education:
Typically, Bachelor's degree (or equivalent) in science or related discipline
Post-graduate qualifications (Master's, Ph D) 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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