The Senior QC Systems Associate will be responsible for leading, coordinating, contributing to and undertaking activities pertaining to Quality Control Deviations, Corrective/ Preventive Actions, Analytical Results Assessments and Change Control records
You will also be responsible for the below duties;
- All activities within the Quality System associated with QC Deviations, CAPA records, Analytical Results Assessments and Change Control.
- Report writing for investigations.
- Own and manage Change Controls through their life cycle for QC.
- Lead, contribute to, oversee, run and participate in Root Cause Analysis, implementing improvements and Corrective Actions.
- Trend analysis of Deviations relating to QC.
- Ensure investigations constantly reflect current requirements and expectations.
- Participate in cross functional teams with colleagues from other departments to assess, communicate and manage information and performance via scorecards and meetings.
- Ensure timely completion of QC Deviations, CAPAs and Change Controls utilizing the appropriate procedures and Quality Management Tracking System (QMTS).
- Ensure timely completion of each stage of the Analytical Results Assessments in line with the Quality Control Out of Specification and Unexpected Results procedure(s).
- Ensure flow of communication to stakeholders.
- Develop and maintain quality systems within QC to ensure ongoing compliance with cGLP.
The next Senior Systems Associate should have a 3rd level degree in Science/Engineering with 4 years’ experience in a Pharma or Biopharma environment. You should also demonstrate excellent knowledge of deviation investigations and CAPA implementation
If you’re looking to work with a world leading Biotechnology company that offers flexible working options, get in touch now!
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