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O'Neill & Brennan
Unit 2, Ballymount Business Park,
Lower Ballymount Road, Dublin 2
Tel: +353 (0)14 569 899
E-mail: dublin@oandbgroup.com
Web: www.oneillandbrennan.com

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Quality Manager (124)

Location: Kildare
Entered: 17 Oct 2017
Salary: Competitive
Duration: Contract
 

Quality Manager (Pharma Packaging Maternity Leave Cover Kildare)

Duties and Responsibilities:

- To manage all validation and qualification activities on site in line with the global qualification and validation process.
- To manage and lead the technical quality team.
- To effectively communicate technical requirements and qualification / validation strategy to clients, suppliers and regulatory agencies.
- To lead quality risk assessment activities to determine validation / qualification scope.
- To deliver qualification / validation meeting industry expectation and commensurate to the risk of the system / operation.
- To ensure that technical quality requirements are communicated and understood within the business.
- To keep abreast on new technologies impacting the business and align with industry expectations and requirements on qualification / validation.
- To act as a technical quality SME during investigation of deviations / complaints etc
- To employ lifecycle management concepts to technical assessments and qualification / validation.
- To metric and communicate validation delivery at the monthly Quality Metrics Meetings.
- Use the QMS to manage deviations, changes and CAPAs.
- Participate as required in regulatory inspections, customer and internal audits.
- Make proposals and implement actions as part of continuous improvement.

Desired Skills & Experience:

- Third level qualification in an Engineering or Scientific discipline.
- Significant experience working within an established Quality System within a Pharmaceutical Industry.
- Experience of pharmaceutical technologies and processes.
- Experience of Qualification / Validation
- Experience of managing a team.
- Knowledge of the regulatory requirements governing quality and Qualification / Validation in the pharmaceutical industry

To apply for this position please send your cv to michelle.clooney@oandbgroup.com or call 01-4569899

 

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