Role Overview

Responsible for the local supervision of the Quality Assurance/ Quality Control (QA/QC) processes and procedures in order to meet the daily site demands of all operations and services requiring QA/QC involvement. Senior team member providing QA/QC services for the testing of raw materials, packaging components, and finished product, and as a support service for production activities, ensuring that all stages of product manufacture and warehouse are in full compliance with the principles of Good Manufacturing Practice (GMP) and other regulatory requirements. This role is responsible for ensuring that the sanitation and cleaning standards are adhered to in the physical plant and grounds.

Responsibilities

• Ensure all training relevant to the position and required tasks are completed and kept up to date. Use assigned initials within cGMP environment.
• All documentation relating to Nelson’s products are kept within Quality Management System (QMS) and adhere to Data Integrity (see POL-002).
• Understanding and adhering to cGMP environment requirements.
• To ensure that all QA/QC duties are managed according to GMP
• Responsibility for the testing of raw materials, packaging components and finished product by applying in-house methods of analysis, specifications and approved samples
• To ensure all tasks performed are in keeping with GMP and monitor that production processes and procedures adhere to its principles.
• To review Manufacturing batch records production documents to ensure all tasks performed are in keeping with GMP.
• Issue controlled copies of Standard Operating procedures and Quality Record Logbooks to production and warehouse
• Issue of controlled Master Manufacturing Instructions and labels to Production and warehouse in accordance with the weekly planning schedule for batch manufacturing.
• To perform weekly environmental monitoring and water testing
• Prepare and send finished product and raw material samples to external laboratories for testing
• Ensure all laboratory equipment calibration and maintenance is kept up to date
• To work closely with all staff on site and especially production staff to ensure a good quality culture and openness
• To co-ordinate customer complaints investigation, in conjunction with the QC and Customer Service departments and provide reports and recommendations as necessary.
• To own and implement improvement projects across the site that increase Quality compliance
• Manage the Quality Management System (QMS) at Spatone and be an expert user in QPulse, the Nelsons QMS platform
• Ensure that GMP and GDP is managed and monitored at all times, including implementation of and compliance with:
  • Dress code
  • Personal hygiene
  • Health & Safety within the production environment
• Provide periodic written reports and metrics to the Head of Quality and the Head of Supply Chain, highlighting the progress against pre-determined quality targets
• Ensure that all QA/QC duties are managed according to GMP/GDP
• Responsible for the testing of raw materials, packaging components and finished product by applying in-house methods of analysis, specifications and approved samples
• Ensure all tasks performed are in keeping with GMP/GDP and monitor that production processes and procedures adhere to its principles
• Ensure methods of analysis and specifications are updated regularly or when necessary
• Ensure all derived data is accurately recorded and stored in the correct files and that any test anomalies are reported to the HoQ via a ‘Quality Incident Report’ or ‘Material Defect Report’
• Authorise the release of raw materials, packaging components and unlicensed finished goods
• Ensure all required retained samples are correctly identified and stored
• Investigate product customer complaints promptly and provide reports and recommendations as necessary
• Facilitate root cause fault finding of production and QA/QC deviations and support recommendation of corrective actions
• Perform periodic audits of the production and warehouse facilities to verify and monitor the applied principles of GMP and GDP and determine that there are no deviations from the planned schedule or requirements of issued batch documentation
• Liaise effectively and professionally with QA/QC employees and employees from other departments
• Provide routine GMP/GDP training where required to employees at the Spatone site on areas relating to QA/QC to ensure a full and thorough understanding of GMP
• Develop and manage the site Hazard Analysis and Critical Control Points (HACCP) process
• Support site validation activities in compliance with appropriate legislation