Posted in Jobs, News
Jim Gleeson at CK Science is currently recruiting for a Director of Quality Assurance to join a successful molecular diagnostics company based in the North West, UK.
As Director of Quality Assurance, you will oversee all Quality Assurance activities for the manufacture of in-vitro diagnostics. Further responsibilities will include:
- Management of the company’s Quality System
- Close interaction with senior management and international regulatory authorities
- Ensuring the highest levels of compliance with all applicable standards and regulations
- Mentoring and development of staff across QA, QC and Compliance
- Selection of methods, techniques and evaluation criteria in order to obtain robust results
The ideal candidate:
- Jim is looking for candidates with the following skills, experience and qualifications:
- Extensive GMP QA management experience, ideally within the diagnostics / medical device arena
- Experience of hosting and managing FDA and other regulatory inspections (ISO 13485 would be particularly useful)
- A background in ISO 13485 management would be advantageous
- Excellent communication skills
How to apply:
For more information or to apply for this Director of Quality Assurance position, please contact Jim Gleeson on 01438 870027 or email email@example.com. Please quote reference CL22921 in all correspondence.
Posted in Jobs
Our client, a Scottish diagnostics company require a Regulatory Affairs Manager on a temporary basis to cover maternity leave.
Reporting to the Quality Assurance/Regulatory Affairs Director you will be responsible for a small team ensuring company activities are in compliance with regulations applicable to the diagnostics industry.
To be considered for this Regulatory Affairs Manager position, you must have the following skills and experience:
- Have experience of working within or in close interaction with the RA team in relation to regulatory submissions or verification activities.
- Be knowledgeable about the requirements of at least one of the following areas, IVD Directive, FDA 510k submissions, cGMP requirements as they impact on RA.
- Have experience in interacting with external partners and regulatory agencies including the FDA.
- Have the ability to build key relationships within the senior management team to promote and direct RA within the organisation.
- Have supervisory experience.
- Educated to degree level in a life science subject or have demonstrable experience in a regulatory affairs position.
How to apply
For more information or to apply for this Regulatory Affairs Manager position, please contact Graeme Pallas on 0191 384 8905 or email firstname.lastname@example.org.
Posted in Jobs, News
Our client is a diagnostics and manufacturing company based in Northern Scotland. They require a product development specialist with protein stabilisation experience to join their team.
Roles and Responsibilities:
A Product Development Scientist, you will provide expertise in the development of diagnostic technologies for cardiac tests, to contribute practically; with a hands-on approach, to the optimisation of assay formats and stabilisation of dried enzymatic based assay architecture to GMP/GLP standards.
You will work in a team to develop a stable reagent formulation to 12 months refrigerated stability, optimise assays to improve clinical performance of products and design in product and process robustness, and demonstrate this through (DoE). You will also develop products to design control while adhering to regulatory bodies. You must be able to ensure ELN records are accurate and present data in meetings to peers and be confident communicating to superior managers. Your role will also involve developing project management and planning skills to belay technicians where necessary.
You must be actively involved in the design and optimisation of immunoassays to improve room temperature stability and reduce (ATE) to an acceptable level. You must also be educated to degree level in an appropriate scientific discipline or possess equivalent commercial experience, and have excellent knowledge and understanding of protein biochemistry and the ability to apply analytical measurements in the IVD industry.Experience in working GMP/GLP standards are essential.
For more information or to apply for this Product Development Scientist job, please contact Barney Smith at CK Science on 0191 384 8905 or email email@example.com. Please quote reference SH21618 in all correspondence.