- Reference: CJ44965
- Job Type: Contract
- Location: Cork, Cork City, Munster
- Category: Science, Pharmaceutical & Food
The change-over of equipment trains from product to product is a key activity for the site; change-overs must be planned for and executed adhering to the site’s fundamental strategies of Safety, Quality, Supply and Cost. Excellence in the safe and efficient change-over of equipment trains from product to product plays a key role in the delivery of products to the markets. The change-over is divided into two sections, namely the PostMI and the PreMI.
- Co-ordinate the PostMI activities in a multi-product manufacturing facility.
- Take ownership of Post-MI section of the change-over to ensure Post-MI is executed to the required safety standard and delivering audit readiness
- Provide process technical support in order to sustain & improve the changeover processes on site
- Coordinate all GMP aspects of the postMI, ensuring the required documentation is in place prior to the start of the change-over, ensuring 100% Manufacturing Right First time during the postMI and implementing sustainable CAPAs following any deviations.
- Using Right First-Time tools, trouble-shoot and provide sustainable solutions for root cause problems.
- Work closely with the Operations, Safety, Engineering, Quality Operations and Value Stream Teams to ensure change-overs are executed with zero SIIs and zero defects
- Identify hazards, assess their relative risk and incorporate recommendations into your designs of the postMI train.
- Effectively use the site business processes to support and to monitor the postMI process e.g. change control, deviations, 6 sigma Method 1 investigations, Area Information Centers etc.
- Work with the Change-over team in leading in the implementation of key change-over projects for the site, targeted at reducing the sites change-over time.
- Align change-overs to Standard Work Plans and lead other Lean initiatives to reduce the overall change-over time on site
- A relevant 3rd Level qualification and/or significant experience in a pharmaceutical environment.
- A demonstrated ability to proactively problem solve solutions to Engineering and Quality scenarios.
- Excellent people and communication skills working in a cross functional team environment.
- Will have the initiative and creativity to identify improvement opportunities and work to see them implemented.
- Strong planning and organisational skills and a proven ability to deliver against timelines.
- A proven knowledge of GMP procedures and the requirements of change controls, Standard Operating Procedures, document control, etc.
- A willingness to learn and be challenged.
- An ability to deal with process change and to implement new and effective processes.
- Demonstrated applications of Lean and Six Sigma tools will be an advantage.
Core Competencies for the role:
- Acts Decisively.
- Seizes Accountability.
- Change Agile
- Peer Relationships
- Grows Self
For a confidential discussion and more information on the role, please contact Eloísa Ruiz on 021 4911063 or email firstname.lastname@example.org
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