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GMP QC Manager - ScotlandRef: BBBH4462
Salary:Up to £0.00 per annum
Added:25 Oct 2018
Just Pharma are currently working on behalf of a biopharmacutical company within Scotland who are searching for a QC Manager.
The post holder will provide leadership to the Quality Control department. In addition, they will ensure the smooth introduction and technical transfer of all new products to production. The post holder will oversee performance of the department from a quality and operational perspective and ensure the most effective use and utilisation of the staff and assets to their disposal. The post holder will work and support the QC Analytical, QC Validation, QC Microbiology and QC Stores, to ensure operational excellence and to exercise overall responsibility for good housekeeping, high standards of cleanliness and compliance to GMP procedures in all areas.
The Quality Control Manager will join a company emerging cancer immunotherapy company developing and manufacturing cell-based treatments for cancer and severe viral infections. Based at their manufacturing facility in the central belt of Scotland, the successful candidate will report directly to the Head of Quality Control. My client is a fast growing, immunotherapy company developing cell-based treatments for cancer patients; moreover, our unique culture, values and working environment attracts, retains, and inspires people to give their best.
RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
- Being accountable for all Quality Control procedures within the multipurpose cleanroom facility.
- Providing specialist GMP and regulatory knowledge, practical expertise, problem solving/troubleshooting skills and good time management ability.
- Managing senior supervisors, supervisors, scientists and technicians across a multidisciplinary team.
- Scheduling of workload across all QC departments to ensure manufacturing timelines are met.
- Overseeing the control, receipt and release of raw materials, and final products to GMP requirements or other.
- Performing, planning, designing and execution of various scientific investigations and studies.
- Being responsible for the preparation of Quality Control documentation.
- Developing structures, policies, processes and procedures to ensure effective and accountable use of resources across the Quality Control department.
- Managing and ensuring that the Quality Control management systems, processes and procedures are implemented across the manufacturing facility to ensure that product released is fit for use and is compliant with appropriate regulations.
- Ensuring that intermediate and final products are analysed in full compliance with the controlled methods and procedures and to GMP requirements.
- Implementing process improvements and actioning the appropriate change controls when required.
- Performing investigations and identifying the root cause(s) for deviations or out of specifications. Preparing impact assessments and risk assessments.
- Ensuring that work is performed in accordance with the Company's Quality Assurance and Health and Safety policies including the provision of COSHH/BIOCOSHH/Risk assessments.
- Ensuring that analytical equipment is calibrated and maintained in accordance with GMP quality systems. Being able to identify deviations and faults in instrument performance and determine an appropriate response to them.
- Training and supervising both experienced and inexperienced members of staff as appropriate, so that technical knowledge and competence is communicated effectively. Where applicable, correcting and coaching colleagues to ensure continuance of a high level of analytical expertise.
- Approval of QC testing data to ensure batch release timelines are met.
- Following, preparing and maintaining documentation to appropriate quality standards, including, but not limited to standard operating procedures, study protocols and specifications.
- Reporting, to the line manager, any deviations occurring during the manufacturing or quality control process and ensure a deviation report is submitted and corrective and preventative actions progressed to completion.
- Degree level education in a biological science discipline.
SKILLS & EXPERIENCE
- At least 5 years working experience within Quality control in a sterile manufacturing facility.
- Previous management experience in a similar role is desirable.
- Previous supervisory experience in a similar role essential.
- Excellent attention to detail with a desire to continually develop and improve our processes.
- The ability to work effectively within a small team.
- Ability to learn and share knowledge with all departments.
- A determination to succeed with a "can do attitude".
- The ability to work under pressure.
- Flexibility and enthusiasm.
- Excellent written/oral communication and interpersonal skills.
- Excellent Microsoft Office skills.
- Thorough approach and high attention to detail.
Please contact Danielle 01707817313 or