- BBBH772158 Dec 17, 2020 Competitive
Exciting opportunity for an experienced Quality &Validation Manager who is seeking a challenging and rewarding role in a dynamic and fast paced organisation. This role is based in Waterford.
Quality and Validation Manager
I am currently working with a leading Waterford based organisation who are seeking an experienced Quality Manager to join their team. This role will report directly to the General Manager.
As Quality Manager you will be responsible for ensuring that the product / service is fit for purpose, consistent and meets both external and internal requirements including; regulatory compliance, legal compliance and customer expectations.
- 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
- 3rd level Qualification in Scientific/technical discipline
- 10 + quality experience in manufacturing
- Ability to introduce and embed new systems successfully
- Thorough understanding of ISO 13485
- 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
This is an excellent opportunity for an experienced Quality Manager who is looking to take the next step in their career in a dynamic and growing organisatio.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF LA CRÈME SERVICES.
Senior Consultant, Office Support, South East
+353 51 309651