QA/QC Chemist

CPL

Waterford

Responsibility. Sampling and testing of raw materials 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 GMPs 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. Minimum 1 to 2 years experience in a regulated pharmaceutical/medical device environment desirable. Degree in Chemistry. Experience of method validation and method transfer. Familiarity with OOS management required. Validation experience within a laboratory. Stability experience desirable. 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. This job originally appeared on RecruitIreland.com.

2172 days ago