Inspection Team Leader

1. Ipsen is a growing and dynamic specialty-driven biopharmaceutical company focussed on innovation and specialty care.
2. We are looking for Dynamic mindset and approach, continuously seeking process improvements through the use of lean manufacturing techniques.
3. We provide competitive salaries and enhanced benefits package which includes annual bonus, generous pension scheme, wellness allowance and so much more.

Ipsen is a growing and dynamic specialty-driven biopharmaceutical company focussed on innovation and specialty care.

The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make a difference. We attract and develop bold, agile and entrepreneurial individuals who take full ownership of their decisions, leaders drawn by a purpose to make a direct impact through their work in people’s lives, all of which is underpinned by our Ipsen Way of Being.

As Inspection Team Leader, you are tasked with leading and contributing to the inspection of filled product according to SOPs and other cGMP documentation. To plan the effective use of resource to ensure that production targets are met for inspection output and turnaround and to lead the team in day-to-day activities in accordance with site EHS and cGMP requirements. First line management of reports will include training, progression, and development to ensure strong team that supports in the delivery of KPIs for Inspection across EHS, Quality and Productivity.

Please note this is a shift based role working 4 on/4 off Days

What will you be doing…

• Ensure the process is performed in a compliant manner in accordance with site procedures and to agreed schedules.
• Ensure vial segregation and tracking is maintained at all times in accordance with site procedures and CGMP.
• Review and complete Batch Records & SAP transactions in a timely and compliant manner prior to QA review.
• Monitor and report process performance KPI data and identify improvement opportunities.
• Communicate performance against schedule to Inspection Production Manager.
• Initiate Quality Event records at the time of the event using ETQ or relevant site systems to ensure that effective CAPA’s are identified and implemented.
• Implement and train out changes to the inspection process designed to maintain compliance with FDA, MHRA or other regulatory requirements.
• Contribute to and implement changes to the inspection process designed to increase efficiencies.
• Initiate and lead problem solving/fault finding activities and implement remedial actions and improvements to drive efficiency.
• Participate in internal and external audits.
• Ensure the process is performed in a compliant manner in accordance with site procedures and to agreed schedules.
• Ensure vial segregation and tracking is maintained at all times in accordance with site procedures and CGMP.
• Review and complete Batch Records & SAP transactions in a timely and compliant manner prior to QA review.
• Monitor and report process performance KPI data and identify improvement opportunities.
• Communicate performance against schedule to Inspection Production Manager.
• Initiate Quality Event records at the time of the event using ETQ or relevant site systems to ensure that effective CAPA’s are identified and implemented.
• Implement and train out changes to the inspection process designed to maintain compliance with FDA, MHRA or other regulatory requirements.
• Contribute to and implement changes to the inspection process designed to increase efficiencies.
• Initiate and lead problem solving/fault finding activities and implement remedial actions and improvements to drive efficiency.
• Participate in internal and external audits.

What are we looking for…

• Experience of managing large automated systems to cGMP or equivalent standards would be considered highly advantageous
• Experience of working in an FDA regulated environment or equivalent and experience of external audits.
• Proven record of supervisory/leadership experience
• Experience of inspecting lyophilised and liquid products or products of a similar nature to CGMP or equivalent standards.
• Thorough understanding of inspection processes
• Competent user of systems such as SAP
• Dynamic mindset and approach, continuously seeking process improvements through the use of lean manufacturing techniques.
• Effective communication skills across all formats with varying levels of seniority

Why Ipsen…

• We are a business that is experiencing exponential growth and transformation, therefore presenting a wide range of opportunities and challenges
• Major £multi-million investment in a New Drug Product Facility to increase the scale and capability of our Wrexham site, ultimately enhancing the products we develop for our customers
• A fantastic culture and working environment with many long-serving employees
• Huge commitment to Diversity & Inclusion - almost 50% of our top 160 leaders are women
• A genuine focus on the environment and sustainability – our Wrexham site is powered by 100% renewable electricity
• Competitive salaries and enhanced benefits package which includes annual bonus, generous pension scheme, wellness allowance and so much more.
• Awarded ‘Best Workplaces’ and ‘Best Workplaces for Wellbeing’ status in the Large Organisations category, as well as ‘Best Workplaces for Women’ in 2023.
• The pride of working for a company that directly impacts and changes lives for the better