·       Participating in reviewing master documents, manufacturing documentation and analytical documentation for compliance with the principles of GMP, as required.  Root Cause Analysis InvestigationsChange Control ReviewDeviation and CAPA investigation, review and plan approval. ·       Write reports of Quality reviews and inspections and escalate as appropriate. ·       Engage with a variety of stakeholders from clients to management to production staff.·       Support management of QMS and eQMS (DOT) ·       Advise management of any deficiencies in regulatory requirements. ·       Partake in Sponsor and Regulatory visits

Act as a Quality contact for the Dundee/Biology Services, and Edinburgh site when required.Participate in reviewing master documents, Study documentation and Analytical documentation where required.Conduct internal audits at the Dundee site, and other CLS sites where required in accordance with site inspection schedules.Write up findings of Quality reviews and inspections of Study documents and report all findings to Test Facility Management and Study Directors / Principal Investigators / Responsible Scientists as applicable.Prepare and issue Quality Statements.Write Standard Operating Procedures.Review Standard Operating Procedures and associated Forms for compliance with principles of GLP and GCP (GCLP), as required.Review and approve equipment qualification and computerised systems validation documentation.Participate in scheduling and conducting external audits.Support the management of the eQMS system.Lead, manage and close out investigations following non-conformances.Perform trending analysis on non-conformances.Review and approve change controls.Review and approve policies.Review and participate in CAPAs and investigations.Carry out and review quality risk assessments.Write training modules on quality topics.Train quality personnel on quality type topics.Perform vendor assurance activities as required.Train other personnel in all aspects of Quality systems and procedures as required.Provide KPI markers for the Edinburgh siteAdvise Management of any deficiencies in Regulatory Requirements.Partake in Sponsor and Regulatory visits as appropriate.Liaise with site personnel to ensure a full understanding of regulatory requirements.Participate in and perform administrative tasks as required.Deputise when Quality Manager not available.

The role involves testing a range of body fluids for drugs and analytes which may have contributed to the individual’s death. This is carried out through the use of specialist extraction techniques such as SPE and subsequent analysis on HPLC-DAD, LCMSMS, GCMS and Headspace GC-FID. A report is then generated and sent to the procurator fiscal. As and when required we can be asked to attend court as an expert witness. Initial screens must be turned around in 3 days or less regardless of workload volume and as such I am adept at working to deadlines and being flexible within my work role. Generation of all the COSHH assessments within the lab and the standard operating procedures currently employed within the laboratory. Maintaining good housekeeping practices, ensuring an adequate supply of stock and that it is done so in a cost efficient and timely manner. Perform toxicological analysis on post mortem body fluids using HPLC-DAD, LCMSMS, GCMS and Headspace GCMS. Ensure an efficient supply of stock within the laboratory. Generation of COSHH and Standard Operating Procedures within Laboratory Act as Expert witness as and when required by procurator fiscal

The role of trainee study director involved utilising SPE extraction methods and LCMSMS to determine the pharmacological profile of compounds in development pipeline of company. As part of the training program, I project managed small studies. This would involve liaising with animal units out with the company, writing protocols, performing analysis and the generation of reports. All of which had to comply with GLP regulations. During my time, I was laboratory safety representative, which involved monthly checks of the laboratory to ensure safety levels were adhered to and the generation of a report of my findings to my line manager. To undertake studies to determine the pharmacological profile of developmental compounds Project manages smaller studies. Ensure all my work adhered to GLP Maintain housekeeping within laboratory and ensure adequate stock Liaise with engineers to ensure equipment was maintained and issues resolved in a timely manner. Laboratory safety representative