Job Description:
As a Quality Control Lead, you will be responsible for the overall management and implementation of quality control processes in our laboratory. This includes managing the Quality Management Systems and Standard Operating Procedures to ensure compliance with ISO 17025 requirements.
You will oversee the planning, coordination, and supervision of all testing within the QC laboratory, ensuring timely completion of samples and adherence to company objectives and relevant Key Performance Indicators (KPIs).
In addition, you will supervise and develop the core QC lab team by mentoring, training, and supporting personnel development plans. You will also represent the QC laboratory in regulatory and customer audits and coordinate the timely close out of non-conformance actions/recommendations identified from relevant audits.
Furthermore, you will maintain GLP compliance in the QC laboratory, oversee QC SOP's updates, change controls, deviations, CAPA's, and laboratory investigations. You will review and ensure application of relevant standards relating to product testing and laboratory compliance, perform product/batch release following review and verification of test results to ensure product/batch compliance.
Other responsibilities include coordinating and supervising laboratory investigations to ensure they are captured, documented, and actioned upon within a timely manner, ensuring the implementation of appropriate corrective and preventative actions as deemed necessary following Quality team review, reviewing and trending lab generated data to ensure continual improvement, and supporting the Quality Department with preparation for Laboratory Management Review and Quality Control meetings.
Required Skills and Qualifications:
* 3rd Level Qualification in Engineering/Science
* 5-8 Years of Experience in Regulated Manufacturing – Medical Device, Pharma, Biotechnology, Life Science
* 5-8 Years Plus in a QC Laboratory environment
* 2-5 Year Management, Supervisor experience
* Working knowledge of ISO 17025 Working knowledge of IVDD 98/79/EC and/or IVDR (EU) 2017/746
Benefits:
* Pension
* Life Assurance
* Disability Benefits
* Paid Annual Leave
* Parking
Others:
* Leading communication with customers regarding technical queries
* Supporting raw material and supplier performance reviews
* Coordinating equipment calibration, maintenance and qualification to the predetermined schedule
* Maintaining lab consumables to ensure continuous supply and no impact on testing
* Ensuring competency and EQA testing-pH and WASP is performed
* Arranging and supporting training, continual improvement and supervision of test personnel
* Providing technical support to QA and Production functions and customers when requested
* Advising, facilitating, and implementing systems to ensure continuous improvement of processes and services
* Ensuring test method and equipment validations are completed on time