We are seeking a highly skilled analytical professional to join our client's site in Waterford on an initial 12 months contract.
Key responsibilities include:
1. Providing expert analytical chemistry services and support to the Site.
2. Effective interaction with other departments on matters related to raw materials, intermediates and finished batch releases. Close contact maintained with Quality Assurance Production, Engineering and Planners.
3. Maintaining, updating and issuing chemical methods, specifications and SOPs in compliance to pharmacopoeial and regulatory requirements.
5. Updating the QC Team Leader on potential problems and highlighting improvements where possible by use of normal communication means.
6. Ensuring all quality documentation and records are complete and current.
7. Ensuring QC laboratories meet current Good Laboratory Practice (cGLP) requirements.
8. Defining and following relevant procedures correctly.
9. Ensuring critical chemical testing and related equipment meets current validation requirements (IQ, OQ, PQ) where required.
10. Auditing and reviewing chemistry test results on a daily basis and ensuring compliance with cGLP.
11. Checking/auditing laboratory notebooks and analytical reports
12. Ensuring compliance to cGMP at all times.
Required skills and qualifications:
* Degree in Science (Chemistry or Biochemistry preferred). Postgraduate studies as appropriate to augment primary degree.
* 2-3 years experience working in a manufacturing environment – ideally part of which would be in the pharmaceutical sector.
* Experience with some of the following tests: HPLC/UPLC, SDS-PAGE, Karl Fischer, HIAC, micro pipetting and ELISA.