Quality Control Analyst / Data Reviewer

About the job

Our Team

Quality Control (QC) is 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. Quality Control Validation Support consists of the Method Validation Group and the Equipment Qualification Group. Quality Control is also responsible for assisting in site-wide studies and projects.

Main Responsibilities

• Perform data review in a timely manner , ensuring adherence to committed scheduled plans

• Perform tasks in accordance with cGMP and HSE requirements, following all associated instructions, procedures, and records

• Verify all expected raw data, calculations, and information to comply with cGMP and data integrity requirements

• Ensure appropriate training and qualification for assigned methods

• Inform management of any quality or HSE events (deviations, out-of-specification results) promptly to ensure proper investigation and impact assessment

• Support i nvestigations to ensure thorough analysis and appropriate impact assessment

• Maintain laboratory facilities and instruments in quality and safety status to ensure appropriate use

Experience with cGMP and laboratory safety requirements

• Analytical testing and data review capabilities

• In depth understanding of data integrity principles and good documentation practices

• Experience with Biologics and/or HPLC/UPLC, CE, ICE techniques

Excellent a ttention to detail and accuracy in documentation

• Strong communication skills for reporting and collaboration

• Problem-solving abilities for investigations

• Commitment to quality and safety standards

• Team collaboration and active participation

• Demonstrated ability to prioritise tasks and adhere to agreed timelines