Are you an experienced Microbiologist? Do you have experience of environmental monitoring? Are you looking to join a growing and evolving business? If yes then this could be the role for you.
Torbay Pharma are currently recruiting an experienced Microbiologist, with a background working in highly regulated industries to join our team based in Paignton. As the Microbiology Specialist - Facilities you will be responsible for ensuring the safety, quality, and compliance of pharmaceutical products by owning the environmental monitoring programme on site.
About Torbay Pharmaceuticals
At TP we have our own special kind of chemistry. Our heritage spans over 50 years with a track record of manufacturing essential medicines across the UK and beyond. With backing from an investment partner are now forging a new path in the private sector.
We are a growing and ambitious business and with this comes opportunities for our people. At TP, we are going places. A career with us means a career helping save lives. We bring skills of all levels and experiences together; not all of our people begin their working lives in pharma.
Together we can make lives better.
About the Role
Reporting into the Site Microbiologist your role is essential in ensuring our facility meets the relevant regulatory quality standards. You will manage the environmental monitoring programme for our facility including our clean room manufacturing and testing environments.
You will be required to work collaboratively with teams across site to meet the business needs and act as a driving force for ensuring that the site meets cGMP compliance and continues to offer an excellent service to its stakeholders.
What you can expect in a Microbiology Specialist role at TP:
- Own and keep current the facility environmental monitoring programme to ensure compliance with cGMP.
- Evaluate environmental monitoring data to identify trends, risks, and potential sources of contamination.
- Own the sampling and testing of the pharmaceutical water system and ensure compliance to cGMP.
- Own the facility gowning process, temperature and humidity monitoring, and pressure monitoring.
- Conduct risk assessments to support the development of contamination control strategies in line with regulatory standards.
- Provide microbiology subject matter expertise across site and during regulatory inspections and customer audit, ensuring the principles of ALCOA++ are upheld.
- Ensure the principles of ALCOA++ are upheld to meet data integrity cGMP.
- Line manage QC Microbiology colleagues, provide training, and manage resource.
- Perform investigations in collaboration with relevant departments to establish root cause and implement effective corrective and preventative actions.
- Maintain facility assets and perform equipment validation activities.
- Use specialised computer programme operations, including but not limited to LIMS, eQMS, and ERP.
- Keep up to date with current industry practice and regulatory compliance.
- Ensure business KBI/KPIs are met and foster continuous improvement.
What are we looking for?
- Bachelor’s degree in microbiology or relevant scientific discipline, or equivalent industry experience.
- Previous experience in a microbiology laboratory ideally within pharmaceuticals but other highly regulated industries will be considered.
- Line management experience.
- Excellent knowledge of EUDRALEX Volume 4 and CFR 21 part 211 to ensure facility compliance to cGMP.
- Able to change and adapt with a growing business.
- Able to understand business delivery targets and supervise the laboratory to success.
- Able to follow gowning and aseptic guidance for delivery of high quality and accurate microbiology work.
- Able to learn new skills and gain process competency within expected timeframes.
- Ability to critically evaluate scientific data packages and interpret data.
What we offer in return
At the heart of Torbay, we offer roles and career opportunities on your doorstep that you won’t find elsewhere. With defined career pathways, and the chance to move between roles and different departments, we support your career journey at every stage. TP is going places. International expansion means growth and new opportunities.
Our benefits set us apart. With 27 days holiday as standard plus Bank Holidays, group life assurance, pension and more - we reward our people for getting the job done.
