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Sr Associate QC (Senior)

  • Job reference: 925658
  • Location: Dún Laoghaire, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences
  • Date posted: 24/05/2019

Senior Associate QC Systems - Investigations/Change Control


This job specification outlines the general responsibilities associated with the role of Senior Associate for QC Systems (Investigations/Change Control) at Dun Laoghaire 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.

Key Responsibilities

* All activities within 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 the flow of communication to stakeholders.
* Develop and maintain quality systems within QC to ensure ongoing compliance with cGLP.

General Responsibilities:

* Audit and Inspection preparation and participation.
* Lead continuous improvement activities to achieve standards of operational excellence.
* Perform tasks and participate on project teams assigned to assist in the timely completion of activities associated with the attainment of group, departmental, team and corporate goals.
* Apply expertise and critical thinking to independently resolve issues.
* Provide technical guidance.
* Be responsible for specific programs and/or projects.

Key Competencies:

* Apply analytical thinking to evaluate and interpret complex situations/problems using multiple sources of information.
* Anticipate and prevent potential problems.
* Excellent verbal and written communication skills including technical writing, presentation and facilitation skills.
* Strong ability to lead teams and effectively utilize team resources.
* Ability to evaluate complex compliance issues.
* Ability to work in a fast-paced environment with changing priorities.
* Excellent Organisational Skills and Time Management.
* Ability to work under minimal supervision.
* Ability to identify and manage competing priorities.
* Skills in the areas of teamwork, flexibility, coaching and motivating.

Knowledge and Experience:

* Hold a third level qualification in a Science related discipline.
* Minimum 4 years' experience in a Biotechnology/ Pharmaceutical/ GMP Environment.
* Knowledge of lab operations, analytical lab techniques, commercialization, and cGMP.
* 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.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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