Daily monitoring and verification of laboratory equipment and completion of associated paperwork.
Receipt and log-in of samples for testing.
Laboratory purchasing and inventory control as required.
Perform analytical testing in accordance with associated regulatory and procedural requirements and ensure that laboratory documentation is kept up to date at all times.
Knowledge of HPLC and/or Dissolution Testing a prerequisite.
Perform instrument calibration and maintenance and complete associated paperwork.
Review of associated calibration and maintenance documentation as required.
Aid in the development of new methods and conduct validation activity as required.
Responsible for the release of products following sterilisation where trained, as a back up to the Microbiologist.
Designee for Microbiologist where trained on relevant procedures/tasks.
Review and approve laboratory testing data as required and reports for release testing of finished product and raw materials analysis.
Completion of laboratory investigations in a timely manner as required.
Perform troubleshooting and fully investigate out of specification results.
Participate in audits (internal and external) and inspections and implement CAPA outcomes as appropriate.
Comply with GLP/ GMP and safety requirements at all times.
Maintain laboratory in a clean and well organised status at all times.
Willing to travel on company business.
Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.
Candidates must possess a third level qualification (degree level) in chemistry/science related discipline.
The ideal candidate should possess at least 2 years experience in a GLP/GMP analytical laboratory environment within the pharmaceutical or medical device industry.
Candidates must be strong technically with the ability to troubleshoot HPLC, and/or dissolution in addition to other analytical instrumentation. Candidates must be capable of working on their own initiative and also be comfortable within a team environment.
Willingness and availability to travel on company business.