Quality Control Specialist

You will be responsible for Quality Control at Rayner’s manufacturing facility in Sousel, Portugal, ensuring work is completed efficiently to timelines and in strict accordance with the Standard Operating Procedures and quality standards.

You will work closely with and under guidance from the Quality Manager and the global Quality Assurance department.

What You'll Be Doing:

• Monitoring aseptic conditions
• Oversee all microbiological controls concerning the raw materials, the production environment, and the equipment
• Investigation of OOS results
• Test/release of incoming materials
• Sampling for control tests such as in-process and final product sampling
• Writing work instructions for cleaning and microbiological control of production rooms
• Maintaining records of analytical and microbiological results
• The application and control of Good Manufacturing Practices (GMP) during each step of the manufacturing processes
• Perform internal audits under the authority of the Quality Manager
• Defining microbiological specifications and standards for raw materials, in-process products and finished products under the authority of the Quality Manager
• Responsible for the batch release procedure together with the Quality Manager
• Control and evaluation of batch documentation as part of the release process, issue of Certificates of Conformity and Certificate of Analysis
• Physical release and transfer of product from quarantine to released status
• Perform validation planning activities together with the Production Manager
• You will work closely with technicians to provide hands-on support to the Production department, guaranteeing smooth implementation and continuous running with minimal downtime
• You will use your professional and technical expertise to evaluate new and existing processes and configure accordingly
• You will work to reduce costs, improve sustainability and develop best practices to drive optimization of the existing manufacturing environment through Process Improvement and innovative ways of working
• You will work across departments (including Operations, QA/Validation and R&D) to investigate and implement the best manufacturing solutions to support Production, capacity increase and new product development
• Liaising with the Head of Quality, set, develop and monitor appropriate KPI’s for your work area and manage performance in the team to consistently achieve those

What Experience & Skills You Will Need:

• Has experience in Quality Control tasks, with a preference for pharma or medical device industry
• Has a hands-on approach to problem solving and understands the need for continuous improvement
• Is able to communicate with a range of people from different backgrounds and levels both verbally and in writing (in English and Portuguese)
• Is able to work as part of a team and on own initiative
• Has the ability and willingness to learn new skills and share knowledge everyday
• Has strong planning and organizing skills, good time management and strong attention to detail
• Is able to manage a demanding workload by prioritizing tasks and projects to meet agreed deadlines and maintain work standards in a busy live Production environment
• Has the ability to read and understand technical drawings
• Competent IT user able to use / learn different packages and systems including AutoCAD
• Proficiency in Microsoft Office (Word, Excel and Outlook)
• Business proficiency in English

What We Can Offer You:

• Comprehensive benefits package
• Global appreciation platform to recognise colleagues around the globe
• Fantastic opportunity to work with highly talented teams and individuals and grow with the business
• Being part of an organisation you can be proud to work for changing the lives of millions of people!