GLP Study Manager, Residues - Testing Lab
Salary: Upto £55,000 DOE (plus additional company benefits).
Hours: Days, Monday - Friday
Our Client, a multi- sited testing company who specialise across a number of different industries - are looking to appoint an experienced GLP Study Manager who will help in implementing new studies and growing the team (forecast growth next year). This position requires someone with a good knowledge of the appropriate GLP standards and any other guidelines required such as SANTE/SANCO and latest regulatory guidelines. You will bring experience of managing projects, including planning and supervision of the work of others, to meet the requirement of scientific work contracted by the Client.
The GLP Study Manager is an important role within our Business as you will be responsible for managing a programme of studies with Sponsors. As GLP Study Manager you will ensure that studies are carried out according to required standards as well as reviewing and approving study data. You will have overall responsibility for the scientific, technical and regulatory conduct of studies as well as for the interpretation, documentation and reporting of results. You will also be in a position to advise Sponsors and Business Development Team on a technical level.
It's a great time to join our Client - who are investing in our growth to meet the demands of the market.
- Ensuring study compliance in line with OECD GLP Principles and any other guidelines required.
- Assist during regulatory inspections (e.g. MHRA) and assist QA in all types of audits as required.
- Plan, co-ordinate and/or supervise studies/analysis according to Study Plans and SOP's in compliance with GLP.
- Ensure all paperwork is completed in compliance with good record keeping principals, correctly and on time and promote regulatory compliance across the group.
- Develop Standard Operating Procedures (SOP's) as required.
- Supervision of the analysis and interpretation of data in conjunction with members of the study team as well as day to day training.
- Record and report results using good record-keeping in compliance with GLP.
- Work with the Operational Manager and Business Development Manager to offer appropriate advice and regulatory guidance to the Sponsor to ensure that studies meet the Sponsors needs and fulfil the necessary GLP criteria.
- Will hold a Degree in a relevant Chemistry / Analytical Discipline as a minimum qualification.
- Essential experience in conducting lab phase residue studies at Study Director level including full knowledge of residue analysis
- Extensive Method Development, Method Validation experience
- Experience in directing studies in accordance with Study Plan, SOP's and regulatory standards (GLP/GMP); ideally will have experience in MHRA inspections
- Experience of managing a programme of projects including proven people management/leadership skills