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 department and the areas they visit as part of their role.

• Work in accordance with the systems in place with regards to health & safety, security and the environment and report any shortcomings or risks.

Other Responsibilities

• Provide regular status updates of current work/projects.

• Provide QA technical support in area of specialisation (including line clearances as required).

• Work with all areas of the KSP Jazz Supply Chain, developing working relationships with other operational departments to help resolve (and prevent) issues.  Performing GEMBA's of the processes.

• Look for continuous improvement opportunities and support operational excellence initiatives.  Both within the QA function and KSP operational areas. 

• Can sign documents ("pp") on behalf of other QA personnel in time of absence, and where training and experience allows.  Deputise for Quality Management as required.

• Undertake other activities, indirectly related or unrelated to the above listed accountabilities, as assigned by line manager/GQLT.

Required Knowledge, Skills, and Abilities

• Working knowledge of office IT packages including Microsoft Office.

• Good level of written and verbal communication skills

• Excellent attention to detail.

• Ability to manage time/workload through effective prioritisation.

• Operates in accordance with the Jazz corporate values of Integrity, Collaboration, Passion, Innovation and Pursuit of Excellence.

• Actively looks for and implements improvements in productivity and efficiency within own work area.

• Typically Bachelor’s degree in science or related discipline

• Typically >1 year post-degree work experience in a GMP environment (pharma, medical devices or other similar industry)

• Knowledge of Quality Systems in the Pharmaceutical Industry is preferred.