The team within Ireland Manufacturing is small and diverse. This role is critical to provide specialised support across a range of functions including manufacturing operations, quality and supply chain. Primary responsibility is process support, and within that the role will require assessing a broad range of site functional processes and implementing solutions and continuous improvements.
The role is a unique opportunity and an ideal platform for an ambitious person to develop enormous breadth in the pharmaceutical industry through working across all functions in a small but expert pharmaceutical manufacturing facility.
- Identify root causes and corrective actions for process and function issues utilising best practice problem solving and continuous improvement methodologies in collaboration with other functions. Prepare and issue reports on same.
- Ensure that processes are functioning at optimum level, to the right rate and quality of output, in order to meet supply demands
- Work closely with leaders and subject matter experts to monitor and where necessary, implement improvement initiatives in line with continuous improvement philosophy
- Generate, Review & approve technical documents to ensure completeness and correctness of documentation such as user requirements, validation protocols, technical reports, batch reports, non-conformances, comparability studies and procedural changes.
- Writing batch records, campaign reports and other miscellaneous reports and documents as needed
- Lead site Continuous Process Verification program and use information to implement early course correction as necessary.
- Lead and Execute Deviation and OOS investigations, prepare reports and associated CAPA
- Prepare and implement changes to improve processes and close CAPAs
- Generate Operations, Quality and Validation documents as appropriate
- Independently lead and manage assigned projects through completion, including technical transfers as required.
- Research processes, technology, regulations, industry practice and other topics in support of objectives
- Keen interest in learning and developing across a number of disciplines and therefore willing to operate across functions in their day to day deliverables
- Effective verbal and written communication skills
- Excellent interpersonal and teamwork skills required to work effectively and efficiently in a team-based environment
- Ability to multi-task in a dynamic environment with changing priorities
- Proficiency with Microsoft products, in particular Microsoft Excel; ability to learn additional software applications, as the need arises.
Quality System Requirements
- Ability to work in a GMP, Regulated environment
- Must comply with Company policies and procedures
- Must have a primary degree in an Engineering or Science related discipline,
- Preferred experience of technical work in pharmaceutical manufacturing or pharmaceutical development in a GMP environment
- Demonstrated ability to perform complex investigations with root cause analyses
- Excellent technical writing skills and be able to write technical reports, batch records, or procedures
- Experience representing at regulatory audits (HPRA, FDA) is desirable.
- Experience of lean systems and operational excellence will be highly regarded
Jazz Pharmaceuticals is an Equal Opportunity Employer.