QC And Stability Chemist

ICDS RECRUITMENT

WATERFORD

QC and Stability Chemist. This roles is operated on a 2 cycle shift currently days and evenings. Core Purpose: A Client company based in Waterford that specialises in the development, registration and manufacture of high potency solid dose products for global markets is currently recruiting for aQC & Stability Chemist. The ideal candidate will be required to support QC and Stability by ensuring all raw materials, packaging, finished products and Stability samples are analysed in accordance with cGxP. The role reports directly to the QC/Stability Team Leaders. Core Responsibilities: To test and complete write up of QC raw material, packaging, finished product and stability samples in a timely & efficient manner. To support all other on-going laboratory functions & requirements. To prepare and review stability summary sheets where required. To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines. To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement. Check own work and that of others for accuracy. To assist in the preparation for internal / customer/ regulatory inspections. Involved in internal investigations e.g. Out of Specifications, Incidents & Deviation investigations etc. Draft, review or revise documentation within the documentation management system. Report any Deviations/Out of Specifications to Senior Chemist and complete in a timely manner. Health & Safety. Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs. Report any defects. Qualifications & Experience. Qualified to a minimum of honours degree level in Analytical Chemistry, Pharmaceutical science or related discipline. At least two years’ experience working in a related technical environment is preferable but not essential. Proficient in the use of HPLC & associated problem solving. Proficient with Dissolution testing. Strong analytical ability. Broad understanding of regulatory requirements for submission of dossiers in EU, USA, Japan and other jurisdictions. Analyse secure relevant information and identify key issues and relationships from a base of information; relate and compare data from different sources, identifying cause-effect relationships.

1358 days ago