Stability and Method Validation Manager (12 Month FTC)

To manage the company stability testing program for new and existing products, ensuring that stability time points are completed accurately, correctly, and in a timely fashion.

To also manage the laboratory validation activities according to the Validation Master Plan (VMP), including analytical method development and validation (chemical and microbiological), cleaning validation, process validation, and laboratory equipment validation projects as required by the Head of Technical.

 

Key Responsibilities

▪ Ensure that the workload of the stability and validation teams is effectively planned, highlighting any issues to the Head of Technical.

▪ Ensure that progress versus the VMP is reviewed regularly and any changes are communicated to relevant stakeholders.

▪ Ensure that the routine stability program is completed and reviewed annually.

▪ Help develop, write and implement stability protocols with the necessary physical, chemical, and microbiological tests.

▪ Help develop, write and implement validation protocols as appropriate and resulting SOPs or work instructions.

▪ Support production validation projects as appropriate

▪ Ensure the production and labelling of suitable samples for stability testing.

▪ Conduct or ensure out of specification investigations are performed in a timely manner and implement any necessary corrective actions.

▪ Where necessary, make recommendations of product shelf life for new products, and confirm product shelf life for existing products, based upon stability results.

▪ Prepare stability reports when required.

▪ Ensure that the stability chambers are maintained, calibrated and validated.

▪ Ensure out of hours response from the team for out of specification stability chambers and effective monitoring and alarms

▪ Represent the Technical department on cross-functional project teams where required.

▪ Manage the Team Leaders, set objectives, carry out regular performance reviews and develop appropriate training plans.

▪ Represent the Stability and Validation Officers at Technical management meetings ensuring two-way communication.

▪ Ensure the Data Integrity policy is followed by the team at all times.

▪ To carry out any other reasonable management requested task. 

 

Qualifications

Person Specification 

 Degree educated or above in a Science subject or qualified by relevant supervisory

experience of stability testing and validation activities

 

Skills & Experience

Essential

▪ Previous experience or knowledge of stability testing and validation of medicinal, food,

or cosmetic products, able to write stability and validation protocols

▪ Supervisory experience in a product development, analytical or stability laboratory role

▪ Experienced in pharmacopeial and/or food supplement requirements

▪ Experienced in development and evaluation of product specifications

▪ Experience in conducting Out of Specification (OOS) investigations

▪ Experienced in outsourcing of testing to suitable laboratories

▪ A good appreciation of Good Laboratory Practice

▪ Strong report writing skills

▪ Good attention to detail

▪ Practical and organised approach

▪ Hands on / active team leader and coach

▪ Ability to plan and prioritise work according to business needs

Desirable

▪ Experience in development of analytical methods for plant materials, vitamins,

minerals, and other food supplements

▪ Experience of HPLC/GC techniques

▪ Previous experience in microbiological analysis or evaluation of results

▪ Previous experience in cleaning validation

▪ Experience of production processes for solids, liquids and creams