On behalf of my client I am recruiting for a Quality Control and Stability Chemist based in a pharmaceutical company in Waterford. The successful candidate will be responsible for ensuring all raw materials, packaging, finished products and Stability samples are analysed in accordance with cGxP
• 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 follows 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 EirGen documentation management system
• Report any Deviations/Out of Specifications to Senior Chemist and complete in a timely manner
• Health & Safety:
a. Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs
b. Report any defects
• 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.
• Proficient in the use of HPLC & associated problem solving, and dissolution testing
• Strong analytical ability and quality orientation
• Broad understanding of regulatory requirements for submission of dossiers in EU, USA, Japan and other jurisdictions
• Analysis – 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
If you are interested in applying for this role, please call Zoe on +353 1 2784671 or email firstname.lastname@example.org
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com