QC Bioanalytical Analyst
11 Months
Dublin
AS23110
We're currently recruiting for an exciting opportunity with a Pharmaceutical organisation based in Dublin.
The role will be responsible for performing analytical testing within the Biologics laboratory.
Duties:
1. Executing and Supporting routine analytical testing with assays such as HPLC Analysis (IEX, SEC, RPLC), UV analysis, Capillary Electrophoresis (CE), PCR testing, Bioassay methods (ELISA methods) and a wide range of compendial methods on Release, In-process, Stability samples in compliance with GMP requirements.
2. Executing and Supporting routine analytical testing with Raw materials onsite.
3. Follow up-to-date practices with reference to pharmacopoeias, specifications, regulations and industry standards.
4. Support the laboratory testing schedule to achieve an efficient QC system.
5. Receive and manage samples that come into the lab for stability, in-process and release testing.
6. Calibrate and maintain all designated laboratory instruments.
7. Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
8. Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
9. Ensure that cGMP standards are maintained at all times.
Education and Experience:
10. 1 - 5 years laboratory testing experience in the Pharmaceutical or Biopharmaceutical industry.
11. Qualification in Science/Chemical Engineering/Biological Engineering.
12. Experience and critical skills in the area of expertise that add value to the business; ideally bioassay and DNA testing, chemistry testing and raw material testing.
13. Knowledge of regulatory/ code requirements to Irish, European and International Codes, Standards and Practices.
14. Knowledge of cGMP & Laboratory Quality Systems.
If interested in this posting please feel free to contact Avishek Singh at or 0872827991 for further information.