Our client, a Medical device company in Cork are currently looking to recruit a Chemist for their site.
The purpose of the Chemist I role is to support the set-up of the new Analytical Chemistry lab in the Cork site. The role will be responsible for the development and qualification of analytical test methods. The role will also involve conducting analytical testing on validation, commercial, stability and non-routine samples. They are responsible for ensuring that all testing is carried out in accordance with cGMP.
This role will work the site transfer team to ensure compliance with the quality system and transfer project timelines are met.
- Evaluate & validate analytical methods across range of techniques (including UPLC, GC, and FTIR) as required to support product transfer.
- Raw material, in- process and finished product testing.
- Ensure all analytical testing is carried out as defined in the Quality System.
- Perform equipment calibration and qualification as required.
- Ensure compliance with mandatory training requirements and ensure that your training records are up to date and compliant to cGMP.
- Complete documentation associated with testing/ method development & Validation/ equipment qualification in a timely manner.
- Review of all laboratory Quality Systems to ensure compliance to cGMP.
- Demonstrate problem solving in delivering process and analytical understanding.
- Provide training (induction/ on the job/ procedures and updates), technical guidance / trouble shooting to laboratory staff including review of associated training records.
- Review and approval of Laboratory results and documentation, as required the trending and charting of data.
- Proficient in the use various software application utilized in the laboratory. As required the development configuration and validation of software in accordance with Boston Scientific and Industry standards.
- Create, review and approve change requests as required.
- Management of laboratory equipment, inventory & spend.
- Be able to communicate clearly and to form strong working relationships with colleagues.
- Work on own initiative and be capable of developing solutions to problems as part of a team.
- Willing to operate in a flexible manner and be able to switch priorities at short notice.
- Be a good team player, organised, accurate, have strong documentation skills.
Education & Experience Requirements
- 2-3 years’ GMP experience as a Chemistry Analyst is required for this role.
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