Operations Support Specialist Project Role | Collins McNicholas

Operations Support Specialist Project Role

  • Reference: CJ45340
  • Job Type: Contract
  • Location: Dublin North, Dublin South, Dublin West
  • Category: Science, Pharmaceutical & Food

Job Description: 
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. 

Role Responsibilities: 

  • 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. 

Role Requirements:

Education:
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). 

Experience: 
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. 

 

Qualities:

  • 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 aisling.lane@collinsmcnicholas.ie

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

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