QC Analyst
Brightwater
Waterford
One of the leading employers in Waterford has a vacancy an for experienced QC analyst to join it's team. Experience in a regulated manufacturing environment is strongly preferred. Principal Responsibilities: ¨ Sampling and testing of raw material, in-process materials, finished and stability products. ¨ Assist at a technical level in out of specification investigation and non-conformance management. ¨ Participate in lab process validations, cleaning validations and equipment qualification. ¨ Participate in site validations for the process. ¨ Involved in ensuring that the laboratory is compliant to regulatory systems. ¨ Sampling and testing of materials, utilities and environment. ¨ Ensure all operations are conducted in accordance with GMP’s and good scientific principles. ¨ Manage documentation and equipment maintenance systems within the laboratory. ¨ Review chemical analysis data of raw materials, in process and finish products and assess the results and action as appropriate. ¨ Control and management of stability activities including the monitoring of stability chambers. ¨ Provide product support by completing line clearances. ¨ Involved in updating documents within the site. ¨ Support quality aspects of materials management including supplier approval, supplier complaints and specification management. Requirements: ¨ Degree in Chemistry with 5 years’ experience in a laboratory environment. ¨ Minimum 1 to 2 years’ experience in a regulated pharmaceutical/medical device environment desirable. ¨ Experience of method validation and method transfer. ¨ Familiarity with OOS management required. ¨ Validation experience within a laboratory. ¨ Experience in the use of HPLC, GC, FTIR, UV, TOC etc. as well as classical wet chemistry analyses. ¨ Full understanding of the requirements of the Regulatory Standards. ¨ Good communication skills. ¨ Self-starter, highly motivated with the ability to prioritize. ¨ Ability to work on own initiative. ¨ High attention to detail. ¨ Experience in using Microsoft Office products. ¨ Experience of team work. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.
2407 days ago