Sean Cormack Email & Phone Number

Gort, County Galway, Ireland

Galway, County Galway, Ireland

Here's a breakdown of each responsibility:Take charge of compliance activities such as CAPA (Corrective and Preventive Actions) and audit programs, ensuring they are conducted effectively and timely.Facilitate personnel training sessions to ensure all staff members are knowledgeable about quality system requirements.Regularly assess compliance with Cerenovus policies, procedures, and regulatory requirements.Identify areas for improvement through audits, assessments, and feedback mechanisms.Utilize thorough and systematic problem-solving methodologies (e.g., root cause analysis, 5 Whys) to identify, prioritize, communicate, and resolve quality issues.Ensure that corrective actions are implemented effectively to prevent recurrence of issues.Contribute to the generation of risk management file documents, including Risk Management Plan, pFMECA, and associated reports.Engage in departmental activities and responsibilities as required, aligning with existing procedures and external regulations.Support and contribute to team efforts to achieve quality objectives and organizational goals.Resolve project issues by collaborating with team members, suppliers, and other stakeholders as needed.Assist department and project leaders in developing and reporting performance and quality metrics.Ensure that metrics are aligned with organizational goals and provide actionable insights for improvement.Review and approve operational, test, and validation data to ensure conformance to technical specifications and performance standards.Communicate business-related issues or opportunities to the next management level, providing clear and concise information for decision-making.By effectively fulfilling these responsibilities, I contribute to the overall success of Cerenovus by maintaining high-quality standards, ensuring compliance with regulatory requirements, and driving continuous improvement across the organization.

Galway, Ireland

Ensuring the maintenance and improvement of the quality management system but also actively involved in various aspects of quality planning, risk management, and compliance. Further Development and Continuous Improvement of QMS:Actively participate in the development and enhancement of the quality management system (QMS) by identifying areas for improvement and implementing necessary changes.Establish and Maintain Risk Management Principles:Implement risk management principles and methods throughout the product realization process in alignment with the company's QMS and ISO14971 standards.Documentation Management:Maintain accurate and up-to-date documentation to comply with quality standards, customer requirements, and regulatory obligations.Quality Guidance and Leadership:Provide guidance and leadership to a team of Quality Technicians, supporting them in their day-to-day manufacturing operations and ensuring adherence to quality standards.Customer Engagement:Develop strong relationships with customer organizations and other project stakeholders, actively seeking feedback and addressing any quality-related concerns or requirements.Quality Review and Root Cause Analysis:Ensuring that processes and procedures meet established standards and requirements.GMP Standards and Compliance:Establish inspection standards, sampling plans, and test methods to ensure product quality and safety.Operations Procedures and Documentation:Prepare and update operations procedures and associated documentation to reflect current best practices, regulatory changes, and quality requirements.Supporting Audits:Support customer audits as well as surveillance and accreditation audits by providing necessary documentation, participating in audit activities, and addressing audit findings in a timely manner.By effectively fulfilling these responsibilities, I ensured that products meet quality standards, regulatory requirements, and customer expectations.

Cornamaddy, Athlone, Co. Westmeath,

- Manage and maintain an effective calibration system ensuring that all equipment is calibrated as per calibration schedule and all calibration records are in accordance with GMP compliant procedures.- Ensure all calibrations activities are carried out per the relevant procedures and regulatory requirements,- Liaise and manage calibration vendors, including external test houses and Mfg./QA Engineering / Supervisors on an on-going basis, taking appropriate action in their support as required.- Trended and analysed the performance data in compiling Monthly Reports and Management Review,- Reviewed and adjusted Calibration SOP's to make compliant with all regulatory requirements.- Act in an advisory capacity on all calibration/troubleshooting issues arising from personnel within the plant.- Lead Continuous Improvement projects to help improve the Calibration Department to be a provider of a quality service for my internal and external customers.- Control and maintain Calibration Budget, reduced overall calibration spending by 25% approx. in 2 years.- Involved in site wide validation activities such as Building Management system and Production process improvements.- Manage and co-ordinate Calibration technician daily work load.- Recommend and coordinate purchases of new and replacement measurement equipment.- Ensure CAPAs, NCs and other open actions items are completed in a thorough and timely manner.

Galway

- Manage and maintain an effective calibration system ensuring that all equipment is calibrated as per calibration schedule and all calibration records are in accordance with documented calibration procedures.- Ensure all calibrations activities are carried out per the relevant procedures and regulatory requirements,- Liaise and manage calibration vendors, including external test houses and Mfg./QA Engineering / Supervisors on an on-going basis, taking appropriate action in their support as required. - Compilation of appropriate monthly reports,- Review calibration SOP's on an ongoing basis to ensure that all regulatory requirements are met.- Contribute to continuous improvement projects within the calibration group.- Act in an advisory capacity on all calibration/troubleshooting issues arising from personnel within the plant.

Galway

-Ensure that all quality checks at preformed and opened NCMR's if needed before releasing Finished Goods in the market.-Create reservation orders on material in warehouse for use in dunnage builts.-Generate Purchase Orders for payment of external vendors.-Liase with Sterilzation facilities to resolve any issues that may arise,-Manage and maintain the control of Dunnage product for all ETO cycles,-Six sigma projects to lean out the wastes within the release process,-Visual Management of daily routines releases,

Galway

-All incoming material received that didn't conform to specifications was moved to Hold area and NCMR opened-Meet with MRBs -Liaise with vendors on returned goods.

Galway

-Ensure that all quality checks were preformed and NCMR's opened if required before releasing Finished Goods in the market.-Liaise with Sterilization facilities to resolve any issues that may arise,

Galway

I trained new and existing operators on various worksteps and ensuring everyone was trained on the correct procedure

Galway

Galway

Worked on the Manufacturing Line

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