|Role Type||Fixed Term Contract|
Job ID: JOB-12344
Chemist II- 23 month Fixed Term Contract
Ready to join one of the truly great companies in Ireland? We have a really exciting job opportunity for a Chemist II based in Cork. Join a super team of people and a company that offers exceptional salaries and rewards. Let’s have a conversation to find out more about what’s important to you.
The purpose of the Chemist II may include some or all of the following: Carry out testing as required. Provide the first point of contact for analysts on technical issues; Stability coordination provision of a single point person for all storage and testing of the stability finished product and raw material batches, Conduct analytical testing on commercial, stability and non-routine samples, in addition to participate in the test method development, validation and technical transfers; Provide support and guidance in the areas of cGMP, Regulatory, Technical Investigations, trouble shooting and training
- Primary commitment to patient safety and product quality.
- 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 your training records are up to date and compliant to cGMP.
- Test method transfer, 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 installation/ qualification as required.
- Liaise with internal BSC department and vendors in the coordination of service visits and contracts.
- 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.
- Proficient in the use various software application utilized in the laboratory. As required the development configuration and validation of software in accordance with Industry standards.
- Create, review and approve change requests as required. Where required approve CR’s as laboratory trainer.
- Understands and proactively follows through on the environment management procedures that have been identified as relevant to position.
- Represent the laboratory on cross functional project teams as required. Attend and represent the laboratories at meetings and communicate information back to management.
- Participate in OOS investigations, utilizing technical knowledge to identify assignable cause and corrective actions.
- Deputise for the Laboratory Supervisor/ Snr Chemist as required.
- Creation of purchase requisitions for laboratory equipment and consumables.
- Management of laboratory inventory and supplies and ordering of same.
- Provide analytical support to process validations.
- Participate on LBP/VIP and Continuous project teams as required.
- If Stability Coordination responsibilities the following additional responsibilities are applicable: Liaise with stability study owners on Stability monitoring/ Schedules/ Testing and results; Coordination of contract laboratories in relation to storage/ testing including all test and storage investigations and review of same; Review stability data generated; Coordinate testing with operations analytical laboratory; Maintenance of stability calendar/ trackers and trending
Experience & Qualifications
- 3-5 years’ GMP experience as a Chemistry Analyst is required for this role.
- Relevant level 8 degree in a Science, Pharmaceutical or similar field
For further information on this role in Cork please contact Aisling Kidney on 0872197421 or firstname.lastname@example.org
Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
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