Job Description

The key responsibility of this role is to provide a wide range of technical support to all aspects of the manufacturing supply chain.

• To work closely with and provide technical support to the Process and Quality Engineers.
• Ownership and Management of internal rejections;
  • Quarantine of defective materials
  • Re-testing, data collection and presentation as required
  • Facilitate technical team review and decision process.
• Daily participation in production meeting.
• Primary contact for all in-coming and out-going Certificates of Analysis and management of positive release system of finished goods.
• Extract, interpret and present regular product quality data reviews
• Regular review/audit of in-coming material quality.
• Prepare for and conduct face to face meetings with plant auditors.
  • BSI & ISO
  • Customer Audits
  • Internal Audits.
• Analysis, interpretation and presentation of technical data
• Management of calibration of all site test equipment. Organize and host service engineers as required.
• Test method development, optimization and validation (Lab co-ops with other locations) and tester certification.
• Ensure integrity through regular audit of product documentation;
  • Raw material specification and certificates of analysis
  • Product Standards & Test Methods
  • Customer Specifications
• Manage product sample preparation, packaging/labelling and shipment.
• Participate and contribute as Product and Process Understanding (PPU) team member.

Required Knowledge, Skills, and Abilities

Experience in using SAP ERP system with use of Quality modules within. Familiarity with ISO 9001:2015 Quality Management Systems. Competent user of MS Excel and Minitab to analyze and present data. Practitioner of statistical tools and techniques where appropriate; gauge R&R, DoE, t-test, ANOVA, I-mR etc. Able to communicate using charts and tables at appropriate level of complexity to support decision making. 5S and GMP organizational skills. Effective cross-functional team working. Quality focused with “Right First Time” mentality. Participation and ownership where appropriate of validation and CAPA programmes. Both Quality and Product Development aspects of the role require strong data based decision making based on risk, contingency and mitigation assessment criteria. Six Sigma methodology.