- Reference: CJ45340
- Job Type: Contract
- Location: Dublin North, Dublin South, Dublin West
- Category: Science, Pharmaceutical & Food
Operations Support Team of Specialists are system and operational process subject matter experts (SME’s). The Operations Support Specialist balances the requirements of day to day support, implementation of system/operational process continuous improvements (CI) and corrective actions, preventive actions (CAPA’s).
The ideal candidate will be self-driven and will be recognized as having a high level of knowledge/skill.
Project management, tracking, monitoring, and implementing initiatives to improve efficiency will be a key requirement.
This role will support the implementation of AMPS (EBRs) in Drug Substance and requires a technical competence around document layout design, writing skills & Human Error reduction through design. The ideal candidate should have experience in executing projects in line with lean / six sigma tool and techniques.
- Support implementation of AMPS in DS proteins
- Support the layout, design, drafting authoring and approval of SOP’s, Forms, Protocols, Electronic Batch Records, Training content & other documents for a multiproduct Biopharma operation through collaboration with the various departmental SME’s.
- Provide SME input into Human Error reduction principals in documentation and other processes
- Design implement & maintain user interface for SOPs & training
- Working to implement a culture of Zero Defects through partnerships with Manufacturing Operations
- Demonstrating company values and competencies
- Providing leadership in the use of OE and Lean principles to optimize our technical and business processes
- Reporting/managing of project metrics
- Assisting with creation & closure of Quality system change controls
- Carry out organizational activities such as co-coordinating communication information.
Third level Qualification in Science, Engineering or equivalent is preferred, though not essential.
Exceptions may be considered where relevant skills/experience and correct attitude and behaviors exist (this may be supplemented by further education in parallel).
1-3 years’ experience working in cGMP manufacturing environment is essential. A track record of achievement and delivering successfully in a team environment is required.
- Previous experience with an electronic document management system (eBRs, PMX)
- PDOCS experience
- Familiarity with Change control, Investigation and Documentation Processes in a manufacturing environment
- An ability to work independently, and as a member of a global team in a dynamic, fast-paced environment that requires flexibility and initiative.
- Experience in a biopharmaceutical or pharmaceutical cGMP manufacturing or regulated environment or equivalent is preferred.
- Excellent communication skills including computer literacy with experience in MS Project & visio
- Excellent attention to detail
- An ability to deal with process change and implement new effective processes.
For a confidential discussion and more information on the role, please contact Aisling on 021 4809118 or email email@example.com
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs, our job searching tips & videos!