Quality Control Specialist

Recently Rayner has acquired a new manufacturing facility in Sousel, Portugal. This new site will support Rayner’s ambition to grow the business by offering a wider portfolio of ophthalmologic products with our IOLs. 

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

You will work closely and under guidance of the Quality Manager and the Quality Assurance department

Your Key Responsibilities will be:

• Monitoring aseptic working conditions.
• 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 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 together with technicians to provide hands-on support to the Production department, guaranteeing smooth implementation and continuous running with minimized 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.

We are looking for someone that: 

• Has experience in Quality Control tasks, with preference for pharma or medical device industry 
• Has a hands-on approach to problem solving and understands the need for continuous improvement 
• Able to communicate with a range of people from different backgrounds and levels both verbally and in writing (in English and Portuguese) 
• Able to work as part of a team and on own initiative. Ability and willingness to learn new skills and share knowledge every day 
• Has strong planning and organising skills, good time management and strong attention to detail 
• Able to manage a demanding workload by prioritising tasks and projects to meet agreed deadlines and maintain work standards in a busy live Production environment. 
• 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)

Experience & Skills:

• Level 6 - Degree
• A flexible and pragmatic problem solver 
• Familiar with Quality System concepts, practices and procedures (e.g. ISO 13485, CFR820)
• An enthusiasm for learning new skills
• Able to work as part of a team and across multi-disciplinary teams on projects and represent the department when required 
• Strong communicator with excellent oral and written presentation skills 
• Strong and confident user of MS Word and Excel 
• Time management – able to manage multiple projects and multiple deadlines 
• Fluent in English and Portuguese