QC And Commercial Stability Data Reviewe

ICDS RECRUITMENT

WATERFORD

QC and Commercial Stability Data Reviewer. 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 a QC & Stability Data Reviewer to support Product Development and Commercial Supply by ensuring all components, raw materials, finished products and Stability are tested in accordance with cGxP. This role reports directly to the QC Stability Team Leader. Core Responsibilities: To review raw data from testing of components/raw materials/finished products and stability in a timely & efficient manner. To manage and control all raw data presented for review and file once completed. To complete required release documentation including commercial stability summary sheets. Trending of finished product and API testing. Complete investigations in a timely and efficient manner where applicable. Identify and action recommendations for improvements. Implement 5S and Lean lab initiatives. To support all other on-going laboratory functions & requirements. 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. To perform additional team tasks as agreed to support effective running of the Business. To assist in the preparation for customer/ regulatory inspections. 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. Have experience in Analytical test methods from the standpoint of Creation & Review and be able to Operate laboratory instrumentation such as HPLC GC, FT/IR equipment. Computer Skills/Excel etc.

1430 days ago