A new opportunity for a QC Chemist to join a multinational pharmaceutical organisation. This opportunity is perfect for someone in an analyst role who is looking to progress their career.
Reporting to the QC Team Lead, the QC Chemist will be responsible for the testing and sampling of materials.
Key responsibilities will include the following:
* Performing analysis of in-process, raw material, final product and stability samples
* Interpreting the raw data and results generated, documenting and reporting as per written procedures and as per schedules in accordance with cGMP and all other regulatory requirements
* On completion of analysis, performing independent data review of all analysis as per schedule. Reporting and documenting of results must be completed accurately and promptly and in accordance with cGMP and all other regulatory requirements
* Sampling of raw materials & process/purified water
* Carrying out the qualification, maintenance and calibration of QC Instrumentation as per schedules, ensuring relevant KPIs are met
* Troubleshooting problems which occur when using instruments and implementing solutions to avoid re-occurrence
* Supporting effective root cause analysis and timely closure of investigations
* Improving laboratory RFT through use of effective root cause analysis and CAPA actions and improving analytical testing processes
* Developing, revising and implementing procedures to comply with appropriate regulatory requirements
* Executing instrument and method validation protocols in accordance with written procedures
* Partaking in QC team meetings and team activities and attending plant meetings as required
* Supporting/participating in Analytical Method Transfer and other validation projects
* Supporting/participating in OpEx projects in QC and on site
* Communicating any non-conformance, instrument malfunction, accident or near miss to immediate supervisor
* Working with management and staff to foster an ethos and culture of safety awareness, where safety is accepted as an integral part of the overall business
* Ensuring compliance with relevant regulations and standards associated with cGMP, including data integrity, ISO 14001, ISO45001, Health & Safety Legislation and Environmental Legislation, as well as all site standards, policies, and procedures
Skills and Experience required for the role:
* Minimum 3 years experience in a relevant QC position
* Experience using Empower and Labware LIMS would be advantageous
* Makes suggestions for improvement, new initiatives, ways to minimise costs and challenges current ways of work to improve efficiency
* Ability to work effectively on one's own
* Ability to coordinate and communicate effectively with the QC Leadership team
* Proven leadership and problem-solving skills
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