Release And Stability Chemist R&D

ICDS Recruitment

Waterford

Release and Stability Chemist R&D- Waterford. Key Purpose. The ideal candidate will be required to analyse stability products to agreed schedules and in accordance with regulatory requirements. Also to assist other R&D groups in the testing of In Process and Finished Product samples as required. The role reportsdirectly to the Release and Stability Team Lead in the R&D Analytical group. Key responsibilities. To test submission stability products in a timely and efficient manner to agreed schedules and in accordance with Regulatory requirements. To assist other R&D groups in the testing of In Process and Finished Products if required. To review test methods and draft stability protocols as applicable. To prepare submission documentation in support of license applications. To take part in any laboratory investigations/troubleshooting. To trend analytical data as required. To liase directly with customers and contract laboratories and attend conference calls as required. To attend internal project review meetings as required. To assist in the preparation for customer/ regulatory inspections. To identify and make recommendations for improvements as part of a team within or outside the department. To ensure that all work is carried out is in compliance with the required standards conforming to company, cGxP and SOPs, To complete all documentation correctly in accordance with cGMP and to peer review documentation as required. To perform additional team tasks as agreed to support effective running of the Business. To support all other on-going laboratory functions & requirements. Minimum Qualifications & Experience. Qualified to a minimum of degree level in chemistry, pharmaceutical science or a related discipline. At least two years experience working in a related technical environment. Skills & Competencies. Broad understanding of regulatory requirements for submission of dossiers in EU, USA, Japan and other jurisdictions. Knowledge of Project management skills. Proficient in the use of HPLC. Working knowledge of Empower laboratory software. Proficient in dissolution testing. Knowledge & proficiency of Microsoft products for example MS Excel, Word & Project, Power-point. This job originally appeared on RecruitIreland.com.

1800 days ago