- Conduct raw material, finished product, In-process, stability and water testing in accordance with SOPs and adherence to Good Laboratory Practices principles (GLP) whilst delivering to test schedule assigned.
- Complete testing and timely documentation write-ups in accordance with Good Documentation Practices (GDP) and delivery to Senior analyst/Designee for review.
- Notify Senior Analyst/manager and escalate any issues with testing, instrumentation or tasks that could impact on testing timelines.
- Notify Senior Analyst/Supervisor 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. Lab 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 lab operations scheduling as issued by the Senior Analyst.
- Champion QC Laboratory initiatives based on continuous improvement and 5S principles.
- Ensure necessary equipment and materials are available for analysis.
- Ensure working area is maintained in accordance with cGLP and internal housekeeping standards. Involvement in internal and external calibrations of instruments as per calibration schedule.
- Carry out ancillary QC tasks, e.g. housekeeping, stock checking as required by the QC Manager or designee to ensure the QC laboratory operation runs seamlessly
- Bachelor’s Degree within a Scientific Discipline essential
- Minimum 2 years’ experience in GMP environment within a pharmaceutical (HPLC) environment.
- Strong HPLC testing experience is essential
- Strong analytical/quantitative skills
- Excellent technical writing skills
- Good understanding of root cause analysis and its application
- 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
- Strong interpersonal skills
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.