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Regulatory and Quality - Quality Assurance/ HSE
Ref: 1064 Date Posted: Thursday 09 Aug 2018
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Entrust People are recruiting for a Quality Manager in Limerick, Ireland.  This is an excellent opportunity to join a who have just developed and refurbished a new manufacturing plant. 
• Regularly monitors how the quality management system is performing and provides reports to senior management on a monthly basis.
• Publish data and reports regarding company performance against set indicators. 
• Liaise with managers and staff throughout the organization to ensure that the QA system is functioning properly. 
• Responsible for internal and external GMP auditing.
• Implement  changes to  quality system, and provides training, tools and techniques to enable production and quality to achieve quality compliance. 
• Understand how to prioritize tasks according to due date and quality assurance requirements. Quality Assurance and Quality Control:
• Promote quality compliance and continuous improvement throughout the business unit 
• Comply with  Quality Assurance compliance objectives  and ensure that targets are achieved.
• Act as team leader and business unit guide for improvements in compliance methods with A&C’s Change Control program. 
• Ensure compliance with national and international standards and legislation.
• Revise or produce new SOPs, programs and protocols necessary for GMP and GDP compliance.
• Ensure product quality meets various standards, as required for their intended use. 
• Oversee the assessment and comparison of supplier and internal product specifications against customer requirements.
• Disseminate quality procedures to all employees.
• Maintain controls and documentation.
• Liaise with customers’ auditors and ensure the execution of corrective actions and compliance with customers’ specifications. 
• Ensure all current SOPs are followed personally and through all quality group employees.
• Ensure timely execution of all work orders. 
• Responsible for coordinating all quality complaints and delegate tasks according to the various departments involved.
• Verify manufacturing practices to ensure that they meet Good Manufacturing Practices standards.
• Support  method development, assay validation and characterization for raw materials and products.
• Identify, evaluate and purchase analytical and laboratory support equipment, as required.
• Revise or produce new SOPs, programs, specifications and protocols necessary for laboratory operations.
• Lead verification/validation activities related to instrumentation.
• Oversee the calibration of equipment as required.
• Direct or perform and resolve out-of-specification investigations and implement corrective and preventative actions.
• Manage internal and external testing through scheduling and execution of quality control testing activities.
• Manage the QC sampling and testing of raw materials and finished products according to established procedures.
• Liaise with suppliers and clients to coordinate transfer of specifications and any validation undertaken by the QC department.
 Manage the water purification system  testing and calibration.
• Manage A&C Bio Buffer stability testing program.
• Manage programs related to retained and testing samples.
• Manage releasing Test Sheet and Certificate of Analysis 
The ideal candidate will have at least 2 years Quality Management experience
API experience.
GMP experience.