A growing biopharmaceutical company requires an experienced QC Manager to lead its manufacturing team. You will be responsible for managing raw material, in-process and final product testing. The role is focused on the chemistry QC but will also involve oversight of microbiology testing. You must be an experienced team leader/manager with significant chemistry experience, particularly in GC, HPLC and/or AKTA.
Principle Responsibilities:
- Responsible for the management of the Quality Control laboratory (QC) including Micro lab within the IOM facility reporting to the Director of Quality and Regulatory Affairs.
- Responsible for the development of QC personnel using appraisals, training and mentoring.
- Responsible for maintenance of the test schedule in support of production and batch release and ensuring capacity is appropriate.
- To ensure all equipment is budgeted, sourced, qualified, maintained and calibrated as required.
- To ensure that both the QC lab and Microbiology lab are safe and suitable.
- To support troubleshooting of equipment, analytical and production processes.
- Responsible for maintenance of the laboratory key performance indicators.
- To ensure Lab Investigation reports, Out of Specification (OOS) processes are followed including Root Cause Analysis.
- To ensure all QC CAPAs, deviations and change controls are completed in a timely manner.
- To work with Tech Transfer in introduction of new or modified test methods to ensure smooth handover.
- Be an active participant of the management team by following-up agreed measures and activities.
- To provide support to senior management including line manager on specific projects.
- To ensure there is a culture of continuous improvement.
- Other related duties/responsibilities as required.
- To drive the removal of extraneous testing within the site in preparation for new products.
Qualifications & Experience
- At least five years' experience from within the pharmaceutical, biotech or fine chemical industries on chemical and pharmaceutical testing.
- Expertise in technical problem solving and troubleshooting processes over a wide range of instrumentation including GCs and AKTAs.
- To have the expertise to look at new equipment such as NMR etc to enable a lean approach to QC testing.
- Experience in microbiology and/or chromatography is an advantage.
- Experience in successfully leading and managing a highly technical team.
- Excellent communication, presentation and mentoring skills.
- High levels of computer literacy, numeric and analytical skills.
- Excellent attention to detail with an energetic and proactive outlook.
- Excellent knowledge on Quality Management system
- Experience in building out QC and Microbiology labs would be an advantage.
- A strong background in Quality control processes within a Manufacturing environment.
- You will have a natural ability to communicate at a technical level to difference audiences within your in house and external customer base.
- To have experience in report writing and KPI management of QC.
- Exhibits energy, drive, determination and continually 'raises the bar'.
- Proven track record in working collaboratively with team members, peers and Senior Management.
- Commercial and industry awareness.
You must have the right to work in the UK. Learn more
- Agency: Cranleigh Scientific
- Reference: 7362
- Posted: 6th May 2022
- Expires: 3rd June 2022
