QC Formulation Analyst

The Manufacturing, Science and Technology (MS&T) function is responsible for leading cross functional teams in identifying the root cause of out of specification results, investigating and resolving production issues to ensure product quality and process reliability, monitoring of process data to identify trends, execute process improvements to increase manufacturing efficiency and working in partnership with R&D to transfer and scale up new products into commercial manufacturing.

MS&T are also responsible for the lifecycle management of all Norbrook products from launch through to ongoing commercial supply, including tech transfer of products between sites / suites and assessment and introduction of new API and materials into Norbrook products.
The QC MS&T Scientist will be responsible for the physical and chemical testing of new materials, as part of characterization and assessment, to support subsequent introduction into commercial products. They will also be responsible for the physical and chemical testing of drug products as part of Out of Trend (OOT) and Out of Spec (OOS) investigations and ongoing Product Remediation / Improvement programmes.

The role will require individuals to work across the MS&T sites and within diverse cross functional teams within the wider organization.

Main Activities/Tasks
Main activities and tasks to include but not limited to:

• Perform physical and chemical analysis of API, excipients for new and existing projects.
• Carry out physical and chemical analysis of drug products to support OOT and OOS Investigations and ongoing product remediation programmes.
• Liaise effectively with teams across R&D, Procurement, Operations, QC and site MS&T teams to advance new material / excipient introduction projects, product improvement initiatives and material / product investigations.
• Maintenance of accurate records, preparation of protocols and reports and SOP’s.
• Ensure adherence to Standard Operating Procedures, and departmental documentation requirements.
• Assist in maintenance, cleaning calibration and validation of equipment as required.
• Notify senior staff of any issues related to equipment failure or performance.
• Ensure adequate stocks of consumables are available as required.
• Maintain clean and safe working environment within the laboratories, following all COSHH and other Health and Safety requirements.
• successful development and commercialization of veterinary pharmaceutical
• Stay up to date with current trends and developing technologies in the manufacturing of veterinary pharmaceutical dosage forms.
• Assisting with training of new staff
• Flexibility, some areas of operation are continuous and will require occasional out of hours support
• Perform any other tasks or responsibilities as assigned by management to support departmental activities.

Essential Criteria:

• Bachelor’s Degree or higher in a chemistry or pharmacy related discipline
• At least 2 years’ experience in industry or academia.
• Excellent computer skills including Microsoft Office suite in particular ability to trend data using an appropriate statistical package e.g Minitab, Excel.
• Enthusiastic and hard-working individual, highly motivated to achieve technical targets with ability to multitask.
• Working knowledge of GMP and (V)ICH requirements.
• Strong problem solving and troubleshooting skills.
• Strong communication skills with a demonstrable record of working cross functionally.
• Experience of physical / chemical test analysis techniques.