We are looking for analysts experienced in method development, method validation or technical transfer of analytical HPLC based testing methods for various Pharmaceutical & MedDev clients, in Dublin Cork, and Galway.
You would need to have HPLC testing experience within GMP compliant facilities testing either raw materials, finished product, in-process samples. You would need to specifically have Technical Transfer experience, and knowledge of associated documentation requirements within GMP regulated setting.
If you are interested in this job apply below.
I also have more senior or indeed junior roles within Engineering, QC, QA, QP, Validation, CQV, PM and other areas of pharmaceutical, medical device, and biologics companies.
Send me an email or simply your CV to schedule a confidential chat (014744692) - to andrius "at" sigmar.ie
What is the Job About
- Testing incoming sample from the manufacturing department (either API, In-Process, Oral Solid Dose or Biologics-based products) under the best practice adherence to GMP, GLP and where applicable FDA regulations.
- Using HPLC as a primary technique to carry out the analysis tests.
- Using secondary techniques like Dissolution, GC, FTIR, and UV/Vis.
- Troubleshooting out of specification results from HPLC chromatograms as well as from the HPLC equipment itself.
- Participate in investigations of deviations and raising CAPA's and Change Controls.
- Author various documents in relation to the company and regulatory compliance.
- Carrying out checks and edits on SOP's.
- Participating in sites Lean based, continuous improvement schemes to increase the throughput of QC lab and reduce waste product.
- Where applicable performing technical transfers on HPLC methods from parent sites.
What are the Job Requirements
- Minimum 10 Months GMP based experience in HPLC testing role.
- Experience of testing either raw material (API), in process, finished product (tablets or capsules), or biopharmaceutical product (biologics) within GMP compliant facilities.
- Experience in using HPLC based techniques and being able to troubleshoot.
- Experience in using techniques like Dissolution, GC, FTIR, UV/Vis.
- Ability to work within a fast-paced environment of a busy QC lab.
- Method transfer, validation and technology transfer experience.
- Experience within GMP facilities of a minimum of 1 year using HPLC technique.
Benefits Within These Jobs
Competitive basic salary between €30,000 and €40,000 DOE. Additionally, Bonus (8-12%), pension, medical cover as well as benefits dependent on the particular company in question.
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