The role is to lead, motivate and manage a specific team, which performs Environmental Monitoring (EM) of critical pharmaceutical manufacturing operations and supports the site’s validation activities. The team also supports the EM programme, compliance and training across site to all functions by providing specialist training in microbiological environmental monitoring methods and water sampling. The team is also responsible in processing EM and water results and generating data summaries and reports.
The post holder will be customer focused and deliver continuous improvement activities and be a subject matter expert for microbiological and environmental monitoring tests and issues encountered during the manufacturing and testing of licensed products.
The post holder will
Lead, motivate and manage the performance and output of the EM Team to ensure that the team objectives are met in a timely manner.
Identify and implement improvements to the site wide EM programme.
Maintain training levels across site to the highest standard for EM and compliance.
Monitor, schedule and ensure efficient throughput of Environmental Monitoring and Water data.
Plan and organise schedules for EM Team to ensure adequate assistance is provided to support critical manufacturing processes.
Escalate, troubleshoot and provide solutions to any unexpected issues arising in the laboratory or during EM.
Perform monthly one-to-one meetings with team members, provide support and monitor their progression against set objectives.
Be involved in writing and updating standard operating procedures relating to environmental monitoring and water sampling.
Conduct investigations, initiate and execute CAPAs and Compliance Action Items in a timely manner. Additionally, generate, write and perform technical review/ approval of EM and validation reports, and result summaries
Attend training courses that contribute to the efficiency of the operating systems and are beneficial to the post holder’s personal development.
Coach and support QC staff by assisting in training and qualifying all production and other staff, as necessary in the techniques and procedures for microbiological environmental monitoring and water sampling.
Support QC staff in carrying out environmental monitoring for critical manufacturing operations.
Operate in compliance with SOPs, c/GMPs and other regulatory requirements.
Execute EM testing if required.
Support microbiological testing and result review/ verification if required.
We are looking for a highly motivated quality professional with drive and passion to inspire and deliver through the team reporting to them. A team player with demonstrated leadership and supervisory abilities. Must be educated to degree level in Microbiology or relevant life-sciences subject, equivalent level qualification or significant experience of working at a similar level in specialist area and ideally have a post graduate qualification in Microbiology. The candidate must have experience working in a pharmaceutical GMP environment and good knowledge and understanding of Environmental Monitoring in Sterile Manufacturing.
The role offers free parking, a range of benefits including 38 days annual leave
Interested in applying, please make contact with Liam@requireconsultancy.com to discuss next steps.