QC Analyst - Waterford

KPC International - Excellence from Concept to CompletionQC Analyst, Waterford

KPC International began operations in 2001, our team of Engineers and Scientists have helped our clients achieve project success all over the world within the pharmaceutical and biopharmaceutical space.

We are looking for QC Analyst for the project based in Waterford, this is 12 months contract, onsite roles.

The QC Analyst will be responsible for sample receipt, testing intermediate production samples, final product samples, and environmental samples to demonstrate that all products meet the standard requirements for CGMP operations. Additional functions include raw material testing, stability testing, assay transfers, and qualification of instrumentation. The Quality Control Operations group supports Laboratory Investigations, Deviation Investigations, CAPA support, Training, and Change Controls.

Main Duties Will Include

• Executing analytical testing in a timely manner, ensuring adherence to the committed scheduled plans
• Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasks
• Recording all expected raw data, calculations, information, related to his/her tasks, to comply with cGMP and data integrity requirements
• Ensuring that he/she is trained and qualified to the assigned analytical testing that requires to be qualified
• Performing the QC data review of executed tests by other analysts in a timely manner, ensuring adherence to the committed scheduled plans
• Informing his/her manager of any quality or HSE event (deviations) in a timely manner to ensure investigation and impact assessment are performed appropriately
• Participating actively to any investigation, where he/she is involved, to ensure investigations and impact assessment are performed appropriately
• Executing assigned CAPAs related to remediation plans, continuous improvements
• Ensuring that his/her lab/facilities, lab instruments are kept in a quality and safety status to ensure that they can be used appropriately.
• Audit and review chemistry test results on a daily basis and ensure compliance with cGLP.
• Checking/auditing laboratory notebooks and analytical reports
• Ensure compliance to cGMP at all time

Requirements / Qualifications:

• Degree in Science or related area (e.g. Pharmacy, Chemistry or Biochemistry).
• 2-3 years working within Quality departments in a GMP facility required, ideally part of which would be in the pharmaceutical / biotechnology industry.
• Good understanding of GMP and attention to detail.
• Excellent communication skills and ability to work effectively in cross -functional teams.

KPC -International offers an inclusive environment where you can broaden your experience, perspective and skills to help make an impact on the lives of others.KPC – International is an Equal Opportunity Employer.