|Job Ref No.:||1023|
|Job Title:||Quality & Validation Manager|
|Experience Required||10+ years Experience|
|Qualifications Required||Third level qualification in Scientific/Technical discipline|
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
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.
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
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