Analytical Scientist

Sigmar Recruitment

Galway

My clientspecialises in the design, development and manufacture of medical device products , with particular focus on peripheral vascular products . They were established in 2006 in Ballinasloe, Galway, the heart of Ireland’s Medical Device Industry.They are undergoing a huge expansion and expect to triple in size over the next five years. Due to this, they are now seeking suitably qualified and experienced Analytical Scientists to join their team. The Analytical Scientist is a key member of the Quality team charged with establishing and operating the Analytical & Mixing labs on site. The Ideal Candidate Qualifications: An Engineering or Quality Assurance Degree or equivalent experience. A minimum of 3 years post qualification experience as a Quality Assurance Engineer or in another Science or Engineering related role within a Medical Device or a regulated environment. Responsibilities: Set up Drug mixing and Analytical Lab testing capability on site. Draft Lab operating and testing procedures. These will include chemical compounding, finished Product testing, and Drug Solution testing. Transfer test methods from existing laboratories in the US. Specification, Procurement, Installation, and Validation of Analytical & Mixing Lab Equipment and associated software packages. Daily monitoring and verification of laboratory equipment and completion of associated paperwork. Recruit, Train and Supervise Lab Technicians. Promotes compliance and excellence within the company to customer requirements and the applicable regulatory standards. Participates in new product/technology development and supports the QA activities as part of an overall project team. Summarizes, analyses and in conjunction with the team draws conclusions and makes appropriate decisions from test results and other process related findings. Defines and implements Quality standards and specifications and helps to ensure that Regulatory requirements are met. Continually seeks to drive improvements in product and process quality. Develops and executes required validations in line with regulatory standards to include equipment, process and product validations. Conducts root cause analysis and implements corrective action in a timely manner. Comply with GLP/ GMP and safety requirements at all times. Maintain laboratories in a clean and well organised state at all times. Conducts audits, including closing out audit findings and creating and determining proper corrective and preventive action. Deals with suppliers and ensures their quality standards are in line with those of the company. Competencies: Demonstrable detailed working knowledge of the medical device industry and in particular combination medical devices. Experienced in new Laboratory set-up. Experienced in test method development and transfer. Has prepared SOPs, conducted IQ/OQ/PQs and/or validations previously in a regulated environment. Instrumentation experience in a regulated environment with one or more of the following techniques: HPLC, GC, FTIR spectroscopy and UV-vis spectroscopy. This includes the controlling software. Agilent ChemStation experience preferred. To apply send your CV or call Rachael on 091 455306 to find out more about this position. I also have a lot of other Chemist / QC Chemist / Analyst / R&D Chemist positions open at the minute - please feel free to call me on 091 455306 to discuss. All applications are dealt with in the strictest of confidence. Sigmar will never send your CV to a third party without your consent. This job originally appeared on RecruitIreland.com.

2802 days ago