Key responsibilities and activities :
- Conduct raw material, intermediate material testing, finished product, In-process, stability and water testing in accordance with Good Laboratory Practices principles (GLP) and SOPs adhering and delivering to test schedule assigned.
- Complete testing and timely documentation write-ups in accordance with Good Documentation Practices (GDP) and pass onto QC Supervisor/Designee for review.
- Notify QC Supervisor / Designee of any issues with methods, testing, instrumentation or materials that could impact on testing timelines.
- Notify QC Supervisor / Designee of any Out of Specification (OOS), Out of Trend (OOT) as soon as they occur.
- Author SOPs, protocols, change controls, reports in-line with GDP as required.
- Maintain Records to GDP in a timely manner, e.g. Laboratory Notebooks.
- Ensure workspace is hazard free and maintained in accordance with GLP.
- Ensure necessary equipment is within calibration and materials are available for testing.
- Ensure good adherence to test and laboratory operations scheduling as issued by the QC Supervisor.
- Champion QC Laboratory initiatives based on continuous improvement and 6S principles.
- Carry out ancillary QC tasks, e.g. housekeeping, stock checking as required by the QC Supervisor / Designee to ensure the QC laboratory operation runs seamlessly.
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
Required experience and qualifications :
- Degree level within a Scientific Discipline is desired
- 1 years’ experience in GMP environment within a pharmaceutical environment desired.
- Customer Focus – takes personal responsibility for speed, quality and accuracy of delivery.
- Self-motivated, determined and able to work under own initiative
- Progressive – Pro- active approach to best practice within the QC function
- Collaborative – a team player who can mobilise managers cross functionally to deliver high quality standards
- Competitive – Self driven with a desire to be the best as an individual and as a business to deliver for our customers
- Ability to work under pressure in a challenging and fast moving environment.
- Excellent oral and written communication skills
- Excellent Reporting skills
- Strong interpersonal skills