If you are a current Jazz employee please apply via the Internal Career site.
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical 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 and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharma.com and follow @JazzPharma on Twitter.
Brief Description:
To support and control the management of controlled documents at the KSP facility and to support complaints and supplier management within the QMS.
Key Responsibilities / Accountabilities
* Control and issue of Master Documents
* Allocation of Document numbers and maintenance of QA logs.
* QualDocs DCG User: creating DCCs, sending out controlled copies to internal/external file holders
* Creation, checking and storage of executed batch documents
* Controlling the GMP Archive area at KSP
* Dealing with DCG email requests
* Project support when required.
* Supplier / Vendor Change Management
* Collating metrics and KPI data
* Operates in accordance with the GW corporate values of being patient driven, passionate, innovative, collaborative, accountable, having integrity and achieving excellence
* The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job.
* The job holder must refer to the EHSS Policy (EHSS_P.01) to understand the current EHSS responsibilities for the role.
Detailed Responsibilities / Accountabilities
* Control and Issuing of Master Documents: Logging, issuing, scanning, filing of master documents.
* Allocation of Document numbers and maintenance of QA logs: Generating new numbers when required and ensuring data is entered accurately.
* Creation and storage of executed batch documents: Creation of batch documents to Production areas for execution, checking of variable data within batch documents and confirming in NAV, archiving of released batches in a timely manner to ensure they are secure.
* QualDocs DCG user: Check of documents (when required) within QualDocs and creating Document Change Control within the system to allow documents to be approved/obsoleted, identifying controlled copies to be sent out, creation of execution copies, maintenance of QualDocs system.
* Control and maintenance of the GMP Archive area at KSP: Retrieving documents from the Document Archive ensuring control and maintenance.
* Dealing with DCG email requests: Action emails sent to the DCG mailbox in a timely manner.
* Project Support: Supporting projects when required.
* Supplier / Vendor Change Management: Facilitating management of supplier/vendor change notifications.
* Collating metrics and KPI data: Weekly and monthly reporting of KPIs and metrics.
* AdHoc: Can sign documents (‘pp’) on behalf of another Document Control Senior Coordinator and Document Control Coordinator, performs duties or projects as required, and actively seeks improvements in productivity and efficiency.
Required Knowledge, Skills, and Abilities
* Working knowledge of Microsoft Word and Excel.
* An organised approach to documentation with an eye for detail.
* Patience and determination to complete tasks.
* Education to secondary level or above, ideally with a scientific background.
* Good communication and person management skills.
* Knowledge in either GMP or in Quality Systems.
* Experience in Audit situations.
Required / Preferred Education and Licenses
* Completion of Secondary school education.
* Typically, minimum of 4+ years relevant work experience in Pharmaceutical, Biotechnology or a related industry.
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.
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