Jason Johal at CK Science is currently recruiting for a Quality Manager to join a new technology and innovation centre based in central London.
The Quality Manager will take day to day responsibility for ensuring company systems and procedures, including those covering laboratory, clinical and regulatory activities, are fit for purpose, consistent and meet external and internal requirements. Reporting to the Head of Regulatory, this role will coordinate the implementation of the company quality management system, provide internal training on quality procedures and monitor performance against agreed standards.
Manage the establishment of the company’s quality procedures to cover its business, laboratory (including interface with GLP and GMP), clinical (GCP) and regulatory activities, including a phased approach based on prioritisation of key initial activities
Work within a multi-disciplinary team and matrix environment to promote the awareness of quality requirements throughout the company and train staff in quality related activities
Coordinate the implementation of a fit for purpose company electronic QMS
Establish, implement and maintain processes, including document control and training, needed for successful performance of the QMS
Review the performance of the QMS at planned intervals to ensure its continuing suitability, adequacy and effectiveness and propose improvements
Manage an internal audit programme and propose and implement corrective actions
Coordinate with purchasing and operational colleagues to establish quality requirements for external suppliers, including audit programme for external third parties
Ensure company inspection readiness and lead regulatory agency and client inspections
Provide compliance support to internal staff by providing advice and facilitate escalation of compliance issues through the appropriate route
The successful Quality Manager will have the following qualifications, skills & experiences:
Be educated to degree level in a scientific discipline (or equivalent)
Have experience in quality-related activities including the maintenance and monitoring of QMS, preferably including experience in a small / start-up organisation environment
Be familiar with global standards related to quality e.g. ISO 9001
Be Familiar with UK and EU regulatory environment for medicinal products, particularly the Good Clinical Practice requirements
Have experience working with GLP or GMP activities
Be pragmatic and practical, highly motivated and able to implement workable quality systems and solutions to enable the mission of the company to accelerate the development of cell based therapies in the UK
If successful, you will be joining a group that is passionate about helping to develop a sustainable Cell Therapy Sector in the UK and who wants to play a pivotal role in delivering new therapies to the clinic. In return there is an attractive salary, coupled with excellent benefits and career progression opportunities.
To apply for this position contact Jason Johal on 01438 723 500 or via email on email@example.com Please quote reference ST26838 in all correspondence. Entitlement to work in the EEA is essential.
CK Science are currently recruiting for a QC Analyst to join a multi-skilled team providing a full range of laboratory services based in Essex, UK.
The laboratory is responsible for the sampling of raw and packaging materials, analysis of raw/packaging materials and product, sensory evaluation, research and development.
As a QC Analyst you will undertake the more complex and advanced analytical methodology in GC, HPLC, FTIR plus other laboratory equipment and methodology to satisfy daily work schedules. You will undertake daily sampling/analysis activities and will ensure all work is carried out to GLP. It is also envisaged that you will be able to deputise for the Laboratory Services Manager as required.
The ideal candidate for this QC Analyst position, you will be degree qualified (or equivalent) in Chemistry and will have experience of a wide range of analytical techniques including GC, HPLC and FTIR. A working knowledge of Syspro, Word, Excel and the day to day operation of the LIMS systems wouldbe highly advantageous.
For more information or to apply for this QA Analyst position, please contact Jason at CK Science on 01438 723 500 or email firstname.lastname@example.org. Entitlement to work in the EEA is essential. Please quote reference ST21191 in all correspondence.
Our client, a world leading Pharmaceutical organisation, are currently looking for a Quality Director to join their Drug Development Group based from their state-of-the-art facilities in Surrey, UK.
Working as a Quality Director, you will be responsible for managing quality systems across the European arm of the group. Your duties will include maintaining GCP, GLP and GMP quality systems including development of SOPs for the group; development of function specific training maps for employees; selection and relationship management of contract research firms; management of audits for both internal and 3rd party partner sites / systems as well as coordinating and approving the final release of clinical products. With full responsibility for the Quality Department, you will also be responsible for full management of the division including recruitment, development and training of staff.
This is an outstanding opportunity to join an early phase drug development group that manages a broad portfolio of new molecular entities from candidate selection through clinical Proof of Concept (PoC).
To be considered for this role, you will meet the following criteria:
PhD in a relevant Scientific subject
A QP license would be advantageous.
Proven practical experience managing GCP, GLP and/or GMP requirements at a Pharmaceutical or similar organisation.
A working knowledge of large & small molecule drug substance manufacturing, analytical laboratories, drug product solid dosage forms manufacturing, parental manufacturing, extemporaneous preparation, PET studies and clinical packaging / labelling operations.
For more information, or to apply for this Quality Director position, please contact Jason Johal at CK Science on 01438 723 500 or email email@example.com. Please quote reference ST20896 in all correspondence.
We are currently looking for a QA Manager with extensive knowledge of GLP to join a Research company based in London, UK.
As QA Manager, you will be expected to develop a QA GLP & GCP laboratory audit strategy and implement an audit program in line with the overall QA strategy. You will also be expected to provide assurance that company GLP & GCP laboratory studies are performed in accordance with GLP regulatory requirements and local laws.
Day to day, responsibilities of this QA Manager will include:
The authoring of QA SOP’s and review of functional SOPs
The implementation of in-house GLP training programmes
The implementation and management of audit programs including audits of Study Reports, Facilities, In Process, Critical Phase, Protocols, Sub-Contractors and Suppliers and signing QA statement on GLP reports and protocols audited.
Project management responsibilities of this QA Manager position will involve providing support to pre-clinical staff and study directors on quality/regulatory issues, providing GLP& GCP laboratory advice and support to pre-Clinical personnel and ensuring project timelines are met.
The ideal candidate for this QA Manager role will hold a Degree, Masters or PhD in a Scientific Discipline (or equivalent) and will have industry GLP regulatory pharmaceutical/CRO experience. As you will be ensuring work is carried out according to GLP & GCP standards and you will be providing guidance and information on all aspects of Quality Assurance related to GLP activities, it is essential that you have experience of QA hands on auditing and Quality System experience including protocol, report, in process, critical phase and suppliers. A good knowledge of pre-clinical processes is also required.
For more information, or to apply for this QA Manager position please contact Jason Johal at CK Science on 01438 723 500 or email firstname.lastname@example.org. Please quote reference ST20673 in all correspondence.
Our client, a manufacturer of a wide range of pharmaceutical and healthcare products based in the North East of England, is currently looking for a Formulation Development Scientist to join their team.
The main purpose of this Formulations Scientist role will be to work on the process and product development of new and existing product lines. You will formulate products into suitable dosage formats and manufacture lab-scale formulations for investigational work. This will involve liaison with other departments on a project basis, carrying out process optimisation studies to identify critical process parameters and preparing protocols and reports with recommendations.
Further responsibilities of this Formulations Scientist role include:
Generating, recording and assessing the quality and validity of data generated and drawing conclusions from this data.
Providing formulation expertise for site concern note root cause exercises.
Training others in the use of laboratory equipment, procedures and methods.
Identifying suitable suppliers and contractors for progression of projects
Remaining aware of developments within the formulation science field.
The successful candidate will be educated to degree level in a Life Sciences discipline. To be considered, you must also have a minimum of three years experience in a formulations role in pharmaceuticals, cosmetics or food, with proven experience in product development processes. Knowledge of GLP and GMP is also required, together with the ability to drive projects and effectively analyse data.
This is a fantastic opportunity for an experienced Formulations Scientist to develop their career with a global pharmaceutical manufacturing company that operates on a worldwide basis.
To hear more about this Formulations Scientist role, please contact Lorna Crombie on 0191 3848905 or email email@example.com, quoting reference DH19050 in all correspondence.
CK Science is the largest independent scientific recruitment company in the UK. Our team of specialist recruiters are here to help you achieve your career ambitions within the scientific industry. We actively offer you careers advice, help with writing your CV, assistance with interview preparation and up-to-date information about the industry. We pride ourselves on providing an honest, straight-forward and trustworthy service to both our clients and candidates. Please visit our website at www.ckscience.co.uk.