Location
Wimbledon, Greater London | United Kingdom
Job description
Day to day management of the company stability testing program for new and existing products, ensuring that stability time points are completed accurately, correctly, and in a timely fashion by the Stability team and analytical reports are reviewed and approved. This is an ideal role for someone who has developed their technical skills and wants to move on to utilise those skills and manage a small team.
Responsibilities:
- Ensure all training relevant to the position and required tasks are completed and kept up to date. Use assigned initials within cGMP environment
- All documentation relating to Nelson’s products are kept within Quality Management System (QMS) and adhere to Data Integrity (see POL-002)
- Understanding and adhering to cGMP environment requirements
- Planning and ensuring timely execution of weekly stability time points, ensuring on time completion and accuracy, highlighting any issues to the Head of R&D
- Lead timely out of specification or out of trend (OOS/OOT investigations) and ensure preventative actions for future occurrence
- Ensure the stability rooms are maintained at correct temperature and humidity 24/7, 365 days per year, and an out of hours process exists for remote monitoring when alarms occur and/or if action needs to be taken to move samples
- Manage the annual servicing and calibration of the stability rooms and the monitoring system
- Ensure appropriate levels are maintained of consumables, chemicals, reagents, and standards for stability testing
- Review and approve analytical test reports from the Stability Analysts
- Develop, write and implement stability protocols with the necessary physical, chemical, and microbiological tests
- Carry out analytical work as required, to ensure time points are completed
- To manage the outsourcing of external testing to contract laboratories
- Ensure the production and labelling of suitable samples for stability testing
- Help to make recommendations of product shelf life for new products, and to confirm product shelf life for existing products, based upon stability results
- Prepare stability reports when required
- Manage the Stability Analysts, help to set their objectives, carry out regular performance reviews and develop appropriate training plans
- Assist with laboratory method and equipment validation and development projects when required
- Ensure the Data Integrity policy is followed by the team
- To carry out any other reasonable management requested task
Requirements
S kills & Experience
- Previous experience or knowledge of stability testing of medicinal, food, or cosmetic products, able to write stability protocols
- Experienced in pharmacopeial and/or food supplement requirements
- Experienced in development and evaluation of product specifications
- Experienced in conducting Out of Specification (OOS) investigations
- Experienced in outsourcing of testing to suitable laboratories
- A good appreciation of Good Manufacturing Practice
- Proficient in Microsoft Excel
- Hands on / active team leader behaviours and coach for the Stability Analysts
- Ability to plan and prioritise work according to business needs
Bonus if you have
- Supervisory experience in a product development, analytical or stability laboratory role
- Previous experience of microbiological analysis or evaluation of results
- Experience in development of analytical methods for plant materials, vitamins, minerals, and other food supplements
- Experience of HPLC/GC techniques
- Experience of Thin Layer Chromatography (TLC) techniques
- Experience of production processes for solids, liquids and creams
Benefits
💰 Annual bonus
🏝 25 days holiday per year PLUS Christmas shut down - whoop!
🌺 Free products and staff discounts to keep you healthy and happy
✨ Paid days off to volunteer for some awesome charities
🚲 Cycle to work scheme, free weekly yoga class
We also have regular socials plus all your standard stuff such as pensions, eye test vouchers and season ticket loans. We can tell you all about what is available to you when you start!
Job tags
Salary
