A QC Analyst is required for a Chemistry team within a Global Pharmaceutical plant based in North Dublin.
The QC Analyst is required to analyse raw material, in-process and finished product as well as stability samples according to the relevant specifications relating to development products while ensuring the documenting and reporting of same is conducted in accordance with good laboratory practices.
The QC Analyst shall carry out most of his/her duties in the Quality Control Laboratory and the primary tasks and responsibilities of the position are as follows.
- Working as directed by the Area Supervisor, in accordance with Company safety policies, cGMP and cGLP.
- Receiving and logging samples into the Laboratory.
- Analysing raw material, in-process, finished product and stability samples associated with development products 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 Analyst's documentation are achieved.
- Reviewing co-workers/analyst documentation (i.e. Buddy System)
- Ensuring that all Quality Systems within the department are adhered to on a daily basis.
- Ensuring correct labelling of laboratory reagents and samples.
- Troubleshooting any erroneous analytical data obtained (Involvement in Lab Investigations Reports)
- 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.
- The successful applicant will possess the following knowledge, skills, qualifications and experience.
- A BSc Degree (life science) in conjunction with at least 18months work experience working within a pharmaceutical cGLP environment (IMB and FDA approved).
- A minimum of 1 years' practical/working experience of HPLC, IC & GC testing methods.
- Possessing excellent attention to detail is a must with ability to critically review analytical data.
- Ability to trouble shoot, identify analytical issues and follow up with corrective actions.
- Ideally the successful candidate will have worked in an R&D environment with dissolution experience
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.