- The QC analyst will be working as directed by the Area Supervisor, in accordance with Company safety policies, cGMP and cGLP.
- Receiving and logging samples into the Laboratory.
- The QC Analyst will be responsible for analysing raw material, in-process, finished product and stability samples according to specifications, primarily HPLC and dissolution.
- Analysing validation samples according to validation protocols and investigational samples as directed.
- Recording results in a timely and accurate fashion.
- Ensuring the Right First Time KPI with respect to Quality Control Analyst’s documentation are achieved.
- Reviewing co-workers/analyst documentation
- Ensuring that all Quality Systems within the department are adhered to on a daily basis.
- The QC Analyst will be responsible for troubleshooting any OOS analytical data obtained and assisting with laboratory investigations
- Helping to ensure laboratory SOPs and specifications are kept up to date and in a state of compliance.
- Training other laboratory staff as requested and appropriate.
- A BSc Degre in conjunction with at least 18 months' work experience working within a pharmaceutical cGLP environment.
- A minimum of 12 months working experience of HPLC & GC testing methods.
- Possessing excellent attention to detail is a must with ability to critically review analytical data.
- Ability to troubleshoot, identify analytical issues and follow up with corrective actions
- Knowledge of validation and tech transfers is desirable
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