- JN -042023-1932016
- Apr 28, 2023
An excellent opportunity for a hands on Quality Manager to join a small but hugely successful Irish business and be a core part of the SLT
The Quality Manager is responsible for delivering and driving quality assurance activities across the business and supporting the full product lifecycle to ensure products are manufactured in accordance with cGMP and all other applicable Regulatory requirements.
The Quality Manager, along with their team will execute the site QA activities in order to protect the safety, and quality of products and ensuring that the business meets their Global Customers requirements and specification.
This position requires a strong leader who will partner closely with the Senior Leadership team.
As with all site personnel, the Quality Manager is responsible for promoting a culture of Regulatory Compliance and Continuous Improvement within the Quality Department.
The responsibilities of the Quality Manager include the following:
- Lead the site Quality Risk Management (QRM) program, provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.
- Lead the site Validation Programme through the approval and management of protocols as required i.e. facilities, process, method validation.
- Lead the quality team in the management of the Quality Management systems ensuring all systems are compliant including but not limited to Non-Conformance/ CAPA Management Change control Activities, Supplier Management Programme, Documentation Management and Customer Complaint Processes.
- Lead in the preparation and hosting of external audits, e.g., Customer Audits, Certification Audits etc.
- Taking a leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement.
- Participate fully in any cross functional training initiatives.
- Motivation, training, discipline and appraisal of Quality Assurance/Control staff.
- Actively foster, in cooperation with other staff, an ethos and culture of safety awareness.
- Ensure timely completion of all SOP, reading, training and assessment.
- Primary Degree in Scientific discipline
- Minimum of 6 years' experience within a highly regulated environment working to GMP principles.
- Strong experience within Quality Assurance. Especially in the areas of Audits (internal, regulatory & customer) and managing and driving a QMS.
- Minimum of 2 years' experience in a people management / leadership role.
- Exposure and experience within Validation
- Strong project management and organisational skills.
- As this is a growing and diversifying business, demonstrating the ability to adapt to changing priorities.
If you would like to find out more about this role please click the 'Apply Now' button below or reach out to Kellie on 021 2300 300
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
- Principal Consultant | Engineering Recruitment - Quality & Validation