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NPI Operations Specialist
3 weeks ago
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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