Michael Page Ltd: Senior QA Officer (Interim)

Role description

As a Senior QA Officer you will be leading a small team of QA scientists and reporting into the QA Manager. You will be starting out on a 6 month rolling contract with a view to go permanent.

As a Senior QA Officer your duties will include:

• Participating and executing all required tasks within the QMS
• Supervising and performing duties within the Quality Assurance department
• Ensuring ongoing site compliance to regulatory bodies (ISO9001, ISO 13485 & HTA), customer requirements and any other areas required by the business
• Preparing and assisting with audits from regulators, notified bodies & customers
• Leading and executing the internal & supplier audit and approval programs
• Managing the site documentation system including all controlled documents, quality policies, quality procedures and quality training
• Investigating and executing CAPA, Change Control, change requests and other associated tools
• Developing and delivering Quality training programs
• Actively building a quality culture within the organization with a continuous improvement process focus and alignment with site goals and group policy
• Reviewing and approving batch documentation, and related documents for batch release and shipment

Who we're looking for

In order to apply for the Senior QA Officer role you must meet the following criteria:

• Minimum experience in a quality role within a manufacturing environment, a BSc or equivalent in science is desirable.
• All Quality management aspects of ISO9001, ISO13485 & ISO14971. Additional experience within a GMP environment, HTA & operation to ICH E6 is beneficial
• Working knowledge of validation and regulatory affairs for ISO9001, ISO13485
• Proficiency and working knowledge of electronic and paper based QMS
• Excellent computer skills. Working knowledge of ERP systems and Q-Pulse is advantageous
• Proficient in root cause analysis using multiple techniques including statistical analysis and lean methods
• Have the ability to use own initiative, manage own time and cope under pressure

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