Quality Manager

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 procedures

• Will 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.