Senior Associate Quality Assurance Specialist; 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.

About the Role:

To support and execute product release at KSP of both In House and CMO products. Provide QA support to Commercial Operational areas.

Review and approve documentation and Quality Records for areas of responsibility, e.g. SOP, Deviation, CAPA, Change Control, Quality Risk Assessment, Reports and Specifications.

Key Responsibilities:

• Batch Document Review of Intermediate, API and Final Products.

• Batch Release and Usage Disposition in SAP of intermediates. and API

• Complete quarantine actions in SAP for material under investigation including rejection of non conforming stock.

• Provide QA technical support to operational areas including participation or leading of Root Cause analysis.

• Author, review or approve quality records such as Deviations, OOS, Change Control and CAPA.

• Author, review and/or approve quality documents such as SOP, forms, validation documents, Growers file notes, master batch documents, protocols and reports for QA and other departments.

Detailed Responsibilities:

Executed Batch Document Review and Release

• QA review of executed in house and CMO batch records to an agreed schedule ensuring that they are clear, complete, and in compliance with company procedures, regulatory requirements, marketing partner requirements and GMP requirements prior to final review and release. (Milled, BDS, API, BDP and Finished product)

• Release of Intermediate and API products.

• Complete material status change and Usage decision in SAP for batch disposition including quarantine of material under investigation and rejection of non conforming stock.

Documentation

• Author, review and/or approve as applicable quality documents such as SOP, forms, validation documents, Growers file notes, master batch documents, protocols and reports for QA and other departments.

• Author or assisting with the assembly of Product Quality Review (PQR) sections or summaries including trending the QMS and collating data for the annual QA report as required.

Quality Records and Compliance

• Lead and support departmental investigations (including deviations, OOS, and complaints) ensuring that they are fully documented, that the root cause has been determined, and that corrective and preventative actions have been introduced, or initiated, as agreed and on time.

• Author, review or approve as applicable quality records such as Deviations, OOS, Complaints, Change Control and CAPA.

• Report compliance failures or unusual trends.

Training

• Ensure training records are kept up to date.

• Take responsibility for their own training and development and ensure that relevant training and competency assessments are complete before undertaking tasks unsupervised.

Auditing and Due Diligence

• Lead or support audits (Internal and external) as required supporting the KSP audit programme .

• Ensure any investigations that could lead to a product recall are brought to the immediate attention of senior staff (including Qualified Persons (QPs) and the Site Director of Quality).

• Ensure that regulatory, marketing partner, Due Diligence and other audits/inspections performed at Jazz KSP are supported with efficient document retrieval and supply of technical information.

EHS

• Responsible for understanding the health, safety, security and environmental protection in their…