- Serve as Technical Support for commercial manufacturing and new product introduction.
- Product Risk management and quality risk management Product SME. Management of change.
- Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support.
- Provide technical input into quality notification by authoring/reviewing/approving investigations.
- Execution of equipment/qualification validation programs; including re-qualification and re-validation.
- Statistical data analysis to support development and commercialisation batches. Support continuous improvement through Lean Six Sigma methodologies. Leading and active participation in projects, system failure investigations and investigation reports,
- Execution/development of change controls.
- Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
- regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
- Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
- Work collaboratively to drive a safe and compliant culture in site.
To apply contact Martin Lynch on 087-344 3581.
Email CVs to firstname.lastname@example.org
|Job Category||Process Engineer|