The Company
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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
Bachelors 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 Ts and Cs.
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