Role: QC Lab Manager, Pharmaceutical
Location: North West, UK
Russell Taylor Group has an excellent opportunity for a QC Lab Manager to join a leading Pharmaceutical Company based in the North West. You will ensure that batches are tested in a timely manner to meet business needs and in compliance with GMP. Perform and supervise validation activities in line with ICH guidelines. Provide leadership and support to all areas of the laboratory, raw materials, stability, IPC, and documentation compliance.
- Management of finished product, stability and raw material testing to ensure results availability in line with business targets and testing performed to GMP standards.
- Support with analytical validation activities
- Raising any/HOQ/QP of any issues that may impact on the business
- Liaising with Planning/Packaging Manager to ensure testing schedules meet packaging timeline requirements
- Ensuring all standard, reagents and consumables are available for testing
- Ensuring all paperwork is issued on time to meet testing schedule requirements
- Liaising with raw material/stability analysts to efficiently test products.
- Reviewing testing as defined by second check process.
- Progressing analytical investigations arising from OOS/OOT/OOE
- To be competent in the preparation and execution of test method and laboratory equipment validation documentation.
- Support the reviewing of laboratory documentation to ensure smooth running of the laboratory.
- Undertake project work as directed.
- Competent in wet chemistry and analytical techniques, including FTIR, UV VIS, HPLC and Karl Fischer.
- Generate QC deviation reports and complete timely and effective investigations of GMP non-conformance in the laboratory.
- Competent in principles and application of data integrity and ensuring the QC team comply with data integrity requirements.
- Perform effective trouble shooting following equipment breakdown
- Accurately work to a consistently high standard
- Maintain good housekeeping standards
- Develop and maintain good working relationships within and outside the department
- Implementation of KPI's to monitor the team's activities and resources and improve efficiency.Key Skills
- QC Analytical Skills - specifically solid dose
- Understanding of analytical validation and instrument qualification
- Experience of managing a small team
- Attention to detail
- Effective time management skills with the ability to prioritise effectively.
- Good team player
- Experience in problem solving
- A minimum of 10 years previous experience within a pharmaceutical environment.
- A minimum of 5 years previous experience of supervising/leading a small team
- A relevant scientific degree
- Experience in Laboratory instrument qualification
- Experience in analytical method development/validation and cleaning validation
- Experience in solid dose testing
- Knowledge of GMP laboratory requirements