This job specification outlines the general responsibilities associated with the role of Senior Associate for QC Systems (Investigations/Change Control) which includes:
* Leading, coordinating, contributing to and undertaking activities pertaining to Quality Control Deviations, Corrective/ Preventive Actions, Analytical Results Assessments and Change Control records.
The role provides technical expertise with a focus on Compliance, Continuous Improvement while implementing a Lean Culture and Right First Time (RFT). The role also represents the QC unit by liaising with internal and external customers. The role may involve carrying out additional work functions that are not described in this specification but are associated with the role.
- All activities within Quality Systems 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.
- Third level qualification in a Science related discipline.
- Minimum 4 years' experience in a Biotechnology/ Pharmaceutical/ GMP Environment.
- Experience with Deviations and Laboratory investigations including CAPA identification and implementation.
- Experience in leading Root Cause Analysis would be advantageous.
- Experience in managing and owning Change Controls would be advantageous.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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