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SalaryJoin us and make a difference when it matters most!
At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.
The Team
The Senior Quality Control Analyst will join the quality team based in Cambridge on a 12-month FTC. You will be an experienced analyst who is competent in a broad range of analytical techniques, providing practical, analytical support within the relevant laboratory teams (QC, Stability and Analytical services). This involves testing incoming raw materials as well as intermediate and finished products manufactured at Cambridge and other contract manufacturers concerning product release testing, shelf life monitoring, process and method validation.
Role and responsibilities
- To carry out the analysis and testing of the Company’s pharmaceutical products and incoming raw materials using a variety of analytical techniques (HPLC, Dissolution, Karl Fischer, wet chemistry techniques, Robotic sample prep systems, automated dilutors) and software packages (LIMS, Empower, Tiamo, Vison, LabX, minitab).
- Carry’s out peer to peer data review of analytical data on appropriate LIMS and documentation systems where applicable
- Maintain accurate, clear and concise written records of all work undertaken, following the analytical methods and making sure all the correct documentation is reviewed and present within the analytical write up, to ensure compliance against registered methodologies and adherence to data integrity. Will Identify OOS results and assist in investigations and take appropriate courses of action.
- Be a point of reference for analytical problems, a "go to person". Will take appropriate action where unexpected results are obtained.
What you’ll bring
- Graduate with a Degree in Chemistry, Pharmacy, Biology or similar scientific area or equivalent knowledge through experience.
- Solid experience working in an Analytical Pharma laboratory. Previous HPLC experience is essential and Dissolution experience is advantageous.
- Ideally be an experienced Analytical Chemist, with a strong background in all or some of the following activities. Method development/validation, method transfer, routine QC and stability processes.
- A good level of knowledge for the manufacture of the products tested and the key attributes of the raw materials in the formulations.
- Systems expert - Is considered an expert in a variety of key analytical techniques and software packages. Previous working knowledge of LIMS system and Empower is ideal
- Report writing, Statistical analysis and data presentation.
- A comprehensive understanding of GMP, Health and Safety, laboratory instrumentation, laboratory practices and plant procedures
What we offer in return
- flexible benefits package
- opportunities for learning & development through our varied programme
- collaborative, inclusive work environment
Diversity and inclusion
Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn’t just the right thing, but also the smart thing to do, as we focus on making a positive difference for our customers and their patients.
