QC Lead Stability Support
Salary up to £28,000
Based in Deeside
We are working with a fast-growing contract pharmaceutical development company. They employ over 100 people with customers all over the world. They are an entrepreneurial business by nature and encourage their employees to shape and become the future of their company. They are seeking a QC Lead to join their Stability team, working on their live-bio business.
What you’ll do:
This role will be responsible for the planning and delivery of QC Stability and Shelf Life activities. This will be mainly based in the microbiology related arm of the business. To put in the frame, this product will be a live-bacteria pharmaceutical, such as a tablet, that will be containing an amount of biotherapeutic microbes. The role of the stability QC will be to ensure that this is at the appropriate cell count, some identification work (the main ID work, and total viable counts is outsourced), in your area, the bench activities will additionally involve Karl Fisher, Disintegration, Average Weight and Microscopy.
This is a GMP compliant environment, specifically delivering on stability, capturing data for Quality Assurance and coordinating a team of QC Scientists.
You will be at the same level in the organisation as other QC Lead’s and report to the QC Manager. There will be a group of QC Scientists reporting into you.
Further activities will be:
- Managing the generation of Stability Protocols
- Ensure Stability testing is completed on time, with right-first-time completion of data tables
- In event of deviation or investigation, coordinate with key colleagues to close these with minimum impact on the project timeline
- Identify key training needed in your time
- Support shelf life extension activities
- Liaise with QC Manager, Project Life Cycle Group Leader, QA Lead, QP and other QC Leads
- Communicate QC issues, track QC Stability activities and communicate project milestones and required target delivery
- Deliver Right First Time (RFT) metrics, and support the QC team in delivering RFT
- Ensure teams complete CAPA’s within the required timeframe
Your background and experience:
We are seeking a Pharmaceutical industry experienced candidate, you will be experienced in stability and QC and have several years experience of working in the industry. This role will supervise and manage colleagues and we are keen for candidates with leadership abilities to apply to this role, perhaps already working as supervisors or individuals able to provide tangible reasons why they feel ready for the step into this level of work.
You will need to be experienced in Pharmaceutical quality, and you will be a graduate in the sciences either chemistry, or bioscience. Please on your application do make clear which of the above areas that you have direct experience of, either on your CV or cover letter.
On this occasion, LiCa Scientific is acting as an employment agency.