A Senior Chemistry Scientist is required by CareerWise Recruitment for a Limerick based medical device company on a 12 month contract basis. The Senior Chemistry Scientist will support in the management of lab activity to ensure testing support to production and project output.
Role of this position
- Support in the initiation, design and prioritization of analytical projects.
- Support in the preparation, review and approval of analytical protocols and reports.
- Selection and approval of chemical raw materials.
- Co-ordination, review and approval of laboratory investigations.
- Preparation and maintenance of test methods, specifications and SOP's in compliance with pharmacopoeial and regulatory requirements.
- Selection of contract laboratories, co-ordination of testing requirements and review of reports received.
- Ensuring GMP/GLP compliance in all aspects of the laboratory functions.
- Working effectively to troubleshoot and solve problems.
- Support Lab Lead in implementing a creative approach to improve accuracy, reliability and productivity within laboratory areas.
- Responsible for compliance in accordance with regulations such as and from, but not limited to, FDA Quality System Regulation, ISO 13485, EU MD Directive/Regulations, FDA Combo Product Regulation 21 CFR Parts 4 with 21 CFR 210/211 as applicable, Japanese MHLW, Health Canada, Brazilian ANVISA, Australian TGA for the company's products including medical devices and combination products.
- Relevant third level Degree and a minimum of 4 years' experience in the medical device/pharmaceutical industry.
- Proven record in method development transfer and validation.
- A strong theoretical and practical knowledge of HPLC's and EMPOWER.
- Very good interpersonal, communication and presentation skills, along with an ability to deliver on targets and deadlines.
- Proficient in the use of MS Office and Chromatography systems software.
Please contact Michelle Galvin today for further information on 091 373938 / email@example.comCareerWise Recruitment (In Search of Excellence)