Our client a leading medical device company located in Galway requires a Chemist for a contract role. The responsibilities of this role include conducting analytical testing on commercial, stability and non-routine samples, in addition to participate in the test method development, validation and technical transfers as required.
- Understands and comply with all the regulations governing the quality systems.
- Delivery of key Quality and Performance Objectives. Maintenance of laboratory scorecards and trackers.
- Ensure compliance with mandatory training requirements and ensure that your training records are up to date and compliant to cGMP.
- Your responsibilities may include test method development and validation, raw material, in process, finished product and Stability testing.
- Complete documentation associated with testing/ method development & Validation/ equipment qualification in a timely manner.
- Ensure all analytical testing is carried out as defined in the Quality System.
- Perform equipment calibration and qualification as required.
- Review of all laboratory Quality Systems to ensure compliance to cGMP.
- Participate in Regulatory, Internal (Auditor/Auditee) and Vendor audit programs as required.
- 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.
- Perform and assist with additional duties as may be directed by the QC supervisor.
- Proficient in the use various software application utilized in the laboratory.
- Create, review and approve change requests as required. Where required approve CR?s as laboratory trainer.
- Creation of purchase requisitions for laboratory equipment and consumables.
- Management of laboratory spend and approval of vendor invoices.
- Level 8 Degree with minimum 1 years? experience in a relevant area.
- Good technical capabilities, communication skills, teamwork abilities and initiative.
- Proven ability to work well as part of a team & on own with minimum supervision
For further information on this Chemist role in Galway please contact Cliona O?Malley on 091730022 / firstname.lastname@example.org
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