An established pharmaceutical and medical device manufacturer requires an experienced QC Stability and Compliance lead to join its team. Your role will be to lead the effective management of stability studies and compliance processes and support activities for a range of products in the Quality Control Department. To be considered you must have significant experience in a QC environment and experience managing stability projects in GMP environments.
- To lead and provide direct support with Quality Control based Stability projects as and when required by Quality Directors Managers and / or QP’s.
- Be responsible and accountable for Stability Studies including ongoing studies annual commitments and developmental studies.
- Generate and maintain a concise and informative Master Stability Schedule that provides visibility of studies pull points and storage conditions to the wider Quality team.
- Participate in the creation and approval of stability study protocols and arranging and overseeing the storage at third parties.
- Manage the trending of all stability data and the compilation of interim and final stability reports.
- Contribute to / review general documents Change Controls and Quality Events which directly affect products manufactured on site including but not limited to the QA/QC review of routine documents
- Compilation and review of QA/QC technical documentation as required.
- Support the review of OOS and Quality Control QE’s. Coordinate the timely completion of critical QE’s and change controls by providing support to departments / QEIO with progression of Root Cause Investigations Risk Assessments CAPA actions and associated document reviews. Support QPs’ with providing updates to enable clear disposition of material in the event of major & critical deviations.
- Support customer complaint investigations (coordinate any investigations which require data review in support of Farnham products)
- Control and validation of the Empower system
- Review impact of changes in legislation for Quality Control on site based on output from the LIAT (Legislation Impact Assessment Team) and coordinate projects where relevant changes are required.
- Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with company values.
- Carry out other reasonable tasks as required by the Line Manger.
Education and Experience
- Be educated to BSC (minimum) in Science or related discipline.
- Possess strong Quality Control experience in a GMP environment within a Pharmaceutical/Medical Device Industry preferably management of stability studies.
- Have minimum 2 years experience in a QC Laboratory in a Lead role with direct reports.
- A knowledge of quality systems and the experience of working in a regulated environment preferred.
- Have a good knowledge of GLP/GMP.
Skills and Attributes
- Strong technical background with an excellent working knowledge of GMP Quality and Regulatory understanding.
- Proven ability to engage and motivate a multi-skilled project team to achieve project goals.
- Ability to communicate effectively at all levels.
- Ability to work under pressure and co-ordinate several activities concurrently.
- Logical and numerate with an aptitude for detail.
- A keen strategic thinker who is willing to apply new concepts and ideas to take the business forward.
Salary £28k - £37k + bonus and benefits
Job Ref: 6137