QC Specialist (12 month fixed term contract)

You will be responsible for:

• Provide QC SME support to the QC department providing day to day technical guidance to QC personnel
• Support the QC management team as required
• Lead and drive execution of method development and transfer, participating in training and execution as both the receiving and transfer laboratory.
• Lead and complete execution of timely deviations, events and change controls.
• Training leads in specific assays overseeing the execution of all training activities for all new personnel.
• Leading the method validation / transfer activities with the generation of protocols and reports and support for ad hoc regulatory supporting studies.
• Drive continuous improvement initiatives thus increasing efficiency as per the QC departments OE program
• Quality control leads on the analytical lifecycle governance program, driving implementation in Alexion Dublin.
• Provide SME trouble shooting support and coaching to testing analysts as required.

You will need to have:

• Bachelor’s degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science with a minimum of 7-10 years of laboratory experience in a cGMP laboratory.
• Good technical knowledge in the area of Chemistry and Biochemistry.
• In depth knowledge of current regulatory requirements for Chemistry, Biochemistry and Microbiology methods in support of cGMP operations supporting clinical and commercial manufacturing
• Good experience in deviation methodology and method trouble-shooting
• Excellent report writing and technical writing skills.

We would prefer for you to have:

Experience in Method Transfer and Validation Activities