Acting as a Quality Lead for all phases of production realization including NPD, NPI, Commercialisation, Sustaining, End to Life.
- Monitor and drive compliance within the development process and/or operations to GMP and the requirements of the QMS within assigned area.
- Trouble shooting quality issues identified during product development and commercialisation and driving solutions to reduce non-conformances.
- Quality input and guidance on Validation planning and documentation utilising risk-based (pFMEA) decision making and driving risk mitigation activities into process development and product quality assurance.
- Quality lead on vendor and part appraisal and approval processes.
- Quality lead on process change and related assessment and implementation of change notification
- Working with project team in the identification and implementation of appropriate statistical techniques and visual control systems to monitor the manufacturing processes.
- Ensure that appropriate quality plans, test methods, test plans, deviations, work instructions, specification and drawings are in place and being adhered to during product development, manufacturing transfer and commercialisation.
- Ability to understand and lead specification reviews, factoring in Company capabilities, and drive alignment with customer on acceptance criteria ensuring Company and Customer specifications/ drawings are aligned. Drive for reduction or elimination of variation from processes and inspections.
- Ensuring that all design/specification /process changes are in line with customer contractual agreements and product safety while facilitating progressive and efficient change management.
- Oversee product testing and release activities, including disposition of non-conforming material, the identification of scope, control of related NC material, root cause and appropriate CAPA actions and thorough documentation of same within schedule.
- Establish and monitor process quality performance to determine when improvement actions are appropriate.
- Key driver in responding to and acting on Customer quality feedback and requests.
- QE review and sign off on QMS documentation and records
- Develop and implement programmes to ensure compliance with regulatory requirements and documented controls and procedures within area
Contract details:
- 6-12 month contract (likely to be extended or go permanent)
- Full time hours
- Starting ASAP
- 3 to 5 days per week on site in Limerick
