Our client, a global leader in innovative components for the Biotech and Pharmaceutical industries, has retained us to recruit a QUALITY MANAGER.
Leading the Quality function on site and contributing as a member of the leadership team this person will;
- Drive a compliant work environment, leading a high performing team to deliver against defined business goals, objectives and key performance indicators.
- Maintain the Sites Quality Management System in line with the relevant Standards and Regulations.
- Ensure compliance to the Corporate quality management systems, policies, procedures and protocols.
- Enhance customer relationships by improving quality performance across key indicators.
- Drive and embed a preventive action culture via root cause investigation, risk assessments in collaboration with Operation’s.
- Provide leadership for the site in regard to customer and / or product requirements.
Additional responsibilities include:
- Host the site Quality Management Review in line with agreed frequency, ensure action follow-up and timely close out.
- Ensure sufficient quality support and competencies are in place to support /network projects to ensure flawless transition into Operations e.g. tech transfer.
- Responsibility for the approval of change controls, qualification of new equipment and/or validation of new processes.
- Identify and drive quality improvement projects.
- Responsible for the quality data trending e.g. CAPA, OOS, Deviations, Customer Complaints and Change Requests and driving quality improvements across the site.
- Interface with customers to ensure concerns/complaints are communicated and effective corrective and preventive actions are implemented in a timely manner.
- Defines audit plans for QA process and internal audits for the plant.
- Ensure capability of hosting of third party audits, ensuring general audit readiness throughout the business.
- Audits suppliers and supports issues of delivery specifications for raw materials and auxiliary materials in co-operation with Quality Systems.
- Final Batch release decision, including responsibility for the execution and final disposition of IPC and incoming testing as well as trending of this data.
- Responsibility for the data gathering and reporting of Annual Product Reviews, as required.
- Prepares monthly QA statistics.
- Establishes the duties and responsibilities of reporting staff, regularly assessing performance and acting as a coach and mentor.
- Interface with other sites with respect to sharing of best practices and harmonisation / standardisation of procedures and practices.
We require candidates with a relevant degree coupled with several years’ experience in a Quality leadership role, in a regulated manufacturing environment. Experience should include Quality Operations and Quality Systems management.
This is an excellent and exciting opportunity to participate in and contribute to the continuing growth of a successful multinational company, with good career development prospects. Please send full career details, quoting position no. G23020 to David Garvey at email@example.com . For an initial confidential discussion, please telephone David on +353 (01) 2867692.