Job Description
ASE-S1-05
Job Purpose
Responsible for the Manufacturing of the pharmaceutical products within designated suites, accountable for the processes within an assigned manufacturing area, working closely with cross functional teams. Ensuring that production KPIs are delivered whilst meeting the highest standards of cGMP and Health & Safety.
Key Responsibility
• Personnel
To support the Cell Leads in ensuring that the Manufacturing targets are achieved within their respective area and working as a team to cover breaks and operational activities.
Ensure that tasks for the oncoming shift are completed and prepared so they are starting from a good position. E.g. parts ready for change overs, materials are readily available, 5S and work place management is in good order.
Take part in root cause analysis / problem solving as part of their development and to develop their process knowledge / understanding.
Closely working alongside Engineering team and Quality team as required to overcome and resolve atypical events.
• Performance
Understand & support KPI delivery, including but not limited to, Changeover time targets, run speed performance and downtime or performance losses.
Being involved in Continuous Improvement initiatives and projects as required such as waste reduction and yield improvements.
A champion of small Kaizen projects and actively involved in Autonomous Maintenance program.
Supporting any validation activities including completion of Validation Protocols and sampling requirements.
Ownership for working environment, delivering work place management processes (5S delivery, GMP of area, stock levels)
Managing own workload and able to resolve issues. Supporting the Co-Ordinator and Shift Manager through inputting of operational data (Downtime reporting, maximo submission)
• Good Manufacturing Practice (GMP)
Good knowledge of the pre-requisite quality requirements and documentation.
Able to raise DCRs for Batch Record & procedure updates to maintain operational & regulatory compliance
To understand and comply to the security responsibilities of the operation.
To ensure machinery is maintained in a safe, clean and tidy condition.
Work areas to be maintained to a good standard at all times including embedding workplace management.
• Other
Carrying out any other reasonable task as requested to help ensure that the production operations maintain supporting demand and achieve improvements in performance, quality and safety.
Additional Job Description:
Primary Location:
GB Cambridge
Job Posting Date:
Job Type:
Fixed Term Contract (Fixed Term)