QC Analytical Analyst
Due to continued expansion of our Clients operations, they are recruiting from a suitably qualified and experienced QC Analytical Analyst . The purpose of this role is to conduct analytical testing on commercial, stability and non-routine samples, in addition to participate in the test method development, validation and technical transfers as required. They are responsible for ensuring that all testing is carried out in accordance with cGMP.
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 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 applications utilised in the laboratory. As required the development configuration and validation of software in accordance with and Industry standards.
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.
Management of laboratory inventory and supplies and ordering of same.
Manage laboratory training process and maintenance to training status.
Provide analytical support to process validations.
Participate on LBP/VIP and Continuous project teams as required.
HETAC Level 8 with minimum 2-3 years experience in a relevant area.
For further information on this QC Analytical Analyst position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie