Job Specification

The Role

• Maintain audit ready status of the QMS for client site.
• 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 & 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, 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 validations.
• Management and responsibility for all aspects of quality in the new site.
• Implementation, management and responsibility for Micro facilities in the site.

 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 chemical and or cleanroom environment is essential.
• Previous experience in personnel management and development, ensuring you are able to 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 in order 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.

 The Benefits 

• Permanent job.
• Competitive salary.
• Opportunity to work for an employer of choice in the region.