NPI Operations Specialist

3 weeks ago


Dublin, Dublin City, Ireland Cpl Healthcare Full time

Cpl in partnership with our client Pfizer are seeking a NPI Operations Specialist

Department: Drug Substance Proteins

Position Reports to: NPI Operations Manager

The NPI Operations Specialist role involves representing the Operations function, providing operational and system support for NPI requirements within the Drug Substance Operating Unit.

The responsibilities cover a range of tasks including detailed design/process mapping, risk assessment, SOP and Batch Record generation, training, and project management.

Responsibilities:

  • Participate in Operational Readiness Activities including Commissioning, Validation, and Verification, and troubleshooting technical issues
  • Create SOPs, paper, and electronic batch records, and conduct assessments
  • Train colleagues on new processes and equipment related to NPI
  • Prepare project schedules and adhere to timelines
  • Manage QTS investigations and change controls
  • Review/approve sample plans and manage samples during NPI campaigns
  • Specialize in operations to ensure safe and efficient facility design

Qualifications:

  • Diploma/Bachelors or equivalent experience
  • 4+ years biopharmaceutical experience
  • Experience with systems such as MCS, MES, SAP, LIMS, and more
  • Knowledge of DS product specific equipment and materials
  • Proficiency in writing technical documents and managing projects
  • Strong communication and problems solving skills

People/Values:

  • Demonstrate Pfizer values of Courage, Excellence, Equity, and Joy
  • Adhere to HR Policies
  • Engage with key stakeholders and encourage recognition
  • Proactively share and seek best practices
  • Effective communication within different functional groups
  • Demonstrate strong time management skills

Working Patterns and Duration:

Day based Monday to Friday with potential on-call support during NPI studies/batches



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