The Company

Our client is a specialist manufacturing company. For maternity cover they are recruiting for a Quality Manager.

The Role

• Will be site based.
  
  
• In this position the Quality Manager will be responsible for the management and implementation of improvements to QA system in support of ISO and EU (GMP) regulatory requirements, investigation of non-conformity, vendor assurance and final product release.
  
  
• Maintain audit ready status of the QMS.
  
  
• Ensure that improvements to product / process are documented and aligned with ISO and cGMP requirements.
  
  
• Responsible for the continuous improvement projects by measuring, analysing and improving systems and processes.
  
  
• Responsible for Non-Conformance management, including reporting, investigation, identification of corrective actions and monitoring effectiveness of actions taken.
  
  
• Ensure the routine testing of incoming raw materials, mixes, in process testing and finished products are performed according to approved specifications and procedures
  
  
• Responsible for QA batch record review and product release
  
  
• Ensure quality critical steps are identified and suitably validated.
  
  
• Develop and report quality metrics to Senior Management – monthly Quality Meetings / Management Review / etc.
  
  
• Monitor quality objectives and compile action plan to reach targets
  
  
• Manage the Internal audit schedule.
  
  
• Conduct external audits to ensure effective supplier management. Lead customer and regulatory audits on-site.
  
  
• Implement preventative actions to improve both process and product performance
  
  
• Implement best working practices and techniques for quality assurance.
  
  
• Management and responsibility of all validation.
  
  
• Management and responsibility for all aspects of quality.
  
  
• Management of a team of 4
  
  The Person
  
  
• Bachelor’s Degree in a scientific area.
  
  
• Previous experience of working in a senior quality role within a manufacturing environment.
  
  
• Experience gained within a pharmaceutical or chemical environment is essential.
  
  
• Experience in personnel management and development, ensuring you can direct your team to successful completion of all tasks whilst maintaining good morale.
  
  
• Thorough knowledge of ISO quality systems and validation principles for manufacturing processes.
  
  
• Understanding and application of QMS processes, tools and techniques
  
  
• Sound working knowledge of ISO9001 and GMP requirements
  
  
• Auditor qualifications essential, Lead Auditor status preferred.
  
  
• Experience of validation of systems and processes.
  
  
• Strong leadership, communication, and influencing skills to work effectively across organizational boundaries and influence decision-makers across multiple sites/regions/levels.
  
  
• With good attention to detail, you approach situations with a meticulous eye on safety, quality and procedures.
  
  
• You will have excellent troubleshooting skills with a focus on finding a solution through to resolution. Good writing and computer skills required for keeping accurate records, writing reports and standard operating proceduresWill be willing to work on a FTC.
  
  The Benefits
  
  Attractive base salary with plenty of OT opportunity.
  
  Working for a forward-thinking growing business.
  
  Good company T’s and C’s