£62k - £89k per annumEstimated
...Pharmacology
Previous Clinical Trial and/CRO/ Bio-Tech /Pharma Experience
Experience and understanding of requirements for a Phase I MHRA Accredited Unit
Experience in business development activities, including feasibility and strategic advice for proposal development...
Suggested
Permanent employment
Rotating shift
£47k - £65k per annumEstimated
...delivery of high-quality studies in the Clinical Pharmacology Unit, in accordance with Simbec-Orion's Quality Management System, ICH-GCP; MHRA Phase I accreditation requirements and The Independent Health Care (Wales) Regulations 2011 at all times.
Assess and develop key...
Suggested
Rotating shift
£31k - £43k per annumEstimated
...Desirable
Analytical Science degree, ideally holding a BSc in Chemistry or Biochemistry
Experience working in a regulated environment (MHRA GCP for labs)
Strong attention to detail, proven ability to manage multiple sample analyses
Familiarity with the setup and use of...
Suggested
£32k - £44k per annumEstimated
...data
Analytical Science degree, ideally holding a BSc in Chemistry or Biochemistry
Experience working in a regulated environment (MHRA GCP for labs)
Strong attention to detail, proven ability to manage multiple sample analyses
Ability to document laboratory...
Suggested
£47k - £67k per annumEstimated
...variety of internal and external stakeholders
Significant previous experience working in a regulated environment (IS0 17025, 15189 or MHRA GLP/GMP/GCP)
DESIRABLE
MSc, PhD or MBA in a relevant discipline
Experience in research work and/or relevant experience...
Suggested
Permanent employment
£61k - £87k per annumEstimated
...variety of internal and external stakeholders
Significant previous experience working in a regulated environment (IS0 17025, 15189 or MHRA GLP/GMP/GCP)
Significant experience in managing GCLP or GLP/GMP studies
DESIRABLE
MSc, PhD or MBA in a relevant...
Suggested
Permanent employment
£56k - £77k per annumEstimated
...clinical pharmacology unit
Experience as the Principal Investigator in First-In-Human studies
Strong knowledge and understanding of MHRA Phase I accreditation requirements
Previous line management experience
Benefits
Hybrid Working
Car allowance...
Suggested
Full time
Hybrid work
....
Requirements
Support QA and Engineering department (Site Services & Maintenance Section) compliance activities to meet FDA, MHRA & ISO 134845 - Medical Device requirements.
Support external QMS audits as and when required.
Management of the site calibration...
Suggested
Contract work
Long term contract
Shift work
£45k - £48k per annum
...reports.
Documentational support for world-wide regulatory submissions.
Assist with Competent Authority registrations including the MHRA and ECREP.
Create Declarations of Conformity.
Review and manage standards database.
Support Management of Patents and...
Suggested
Permanent employment
Full time
Contract work
Immediate start
Hybrid work
Holiday work
£30k - £43k per annumEstimated
...competency.
SKILLS REQUIRED
ESSENTIAL
BSc Science Degree
Experience working in a regulated laboratory environment (e.g., MHRA GCP for labs, GLP or GMP)
Ability to use and troubleshoot ELISA analytical systems
Ability to develop and validate analytical...
Suggested
Permanent employment
Contract work
£27k - £36k per annumEstimated
...improvement to validation system; streamline processes. Identify risk areas and required mitigation to meet regulatory inspections e.g. MHRA, FDA, Notified Body etc. through routine compliance activities and specific validation projects.
If you want a multi-dimensional 3D...
Suggested
Long term contract
£40k per annum
...reports.
Documentational support for world-wide regulatory submissions.
Assist with Competent Authority registrations including the MHRA and ECREP.
Liaising with all department to obtain required documentation for technical file and registration updates.
Create...
Suggested
Permanent employment
Full time
Immediate start
Work from home
Holiday work
Working Monday to Friday
£30k - £43k per annumEstimated
...Company Procedures, and pharmaceutical industry guidelines and standards, including but not limited to ICH, USP, Ph.
Eur., JP, ISO, MHRA, FDA, PMDA regulations. Ensure that all work and working practices are carried out to the appropriate quality standard.
Work...
Suggested
For contractors
Fixed term contract
Long term contract
