Job Description

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