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Quality & Validation Manager

Quality & Validation Manager

Job Overview

Job Ref No.:1023
Job Title:Quality & Validation Manager
Location:Waterford
Job Type:Permanent
Duration:Permanent
Salary:Undisclosed
Experience Required10+ years Experience
Qualifications RequiredThird level qualification in Scientific/Technical discipline
Start Date13/02/2020

Job Description

Reporting to the CEO, the Quality manager’s aim is to ensure that the product or service of the organisation is fit for purpose, consistent and meets both external and internal requirements. This includes regulatory compliance, legal compliance and customer expectations.

ISO 13485, AS -9001
Post graduate degree in a technical or regularity discipline desirable

3rd level Qualification in Scientific/technical discipline

Ability to introduce and embed new systems successfully

Thorough understanding of ISO 13485

10 + quality experience in manufacturing

Experience in subcontract manufacturing with numerous product lines

Experience in Quality management, including quality systems management.

Experience leading and developing teams

Experience with FDA regulations desirable

Quality

Remain up to date with ISO requirements and ensure company is audit ready

Plan and monitor internal audit schedule

Quality system development, implementation & maintenance

Ensuring that processes meet with ISO and AS requirements.

Assessing product specifications and customer requirements and ensuring they are met.

Agreeing in-house standards for quality

Monitoring performance by gathering data and producing reports.

Supervising the programme of internal auditing and calibration.

Development, Maintenance and Approval of Standards.

Managing quality issues to ensure timely and effective corrective actions to prevent re-occurrence

Providing support to Regulatory and Customer audits

Monitoring the ongoing performance and outputs of the quality process and providing updates to managers and directors around quality issues.

Supplier and Customer Liaison on Quality Issues.

Provide validation expertise to maintain validated status for the facility.

Oversee the design and execution of commissioning and validation protocols on manufacturing equipment, software and process, and approve validation documentation.

Maintain an understanding of cGMP regulations and guidance in relation to all aspects of qualification of process and equipment.

Coordinate validation activities to ensure schedule adherence and compliance.

Using statistical analysis, measure, control and improve on product and process robustness.

Personnel

Maintain a positive department attitude and ensure that all employees under your supervision are aligned with the company goals.

Proactively, through the use of team meetings and other communication skills, develop sustainable goals and targets for each team within the area.

Lead and develop team

Conduct Performance reviews, RTW, probation reviews etc

Hire/interview as needed. (Operation manager to have input)

Discipline as required in line with current procedures

Design, maintain and implement training programmes as agreed with management

Manage holiday schedule

General Duties

Housekeeping –Maintain Standards

HR Policy -Know and administer HR Policy

Health and Safety - Be pro-active in identifying and addressing any Health and safety issues that arise.

Liaise with other departments/sites in Company
*The above is not an exhaustive list of duties; you may be required to fulfil other duties anywhere throughout the company as required

To Apply