Quality and Validation Manager- Waterford.
In this role you will 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. Core Responsibilities:
- 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
- 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.
- Co-ordinate 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
- Discipline as required in line with current procedures
- Design, maintain and implement training programmes as agreed with management
- Manage holiday schedule
Quaifications & Experience:
- 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.
- Post-graduate degree in a technical or regulatory discipline desirable (not essential)
- 3rd level Qualification in a scientific/engineering/technical discipline
- Thorough understanding of ISO 13485
- At least 10 years' experience in manufacturing
- Ideally 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