Quality Assurance Officer

Nature, nurture and wisdom We believe nature holds the key to our emotional and physical wellness, providing gentle yet effective remedies. At Nelsons, we harness these powerful ingredients and infuse them with centuries’ worth of expertise to offer traditional treatments for a modern world. We’re an award winning, family-owned business, whose passion for providing natural healthcare choices since 1860 continues to drive us today. Nelsons is one of the UK’s leading and Europe’s longest established manufacturer of natural healthcare products, having built up an impressive portfolio including the world-famous RESCUE® Remedy and Teetha® What’s next? Growth, and lots of it! We’re experiencing a significant and exciting period of digital transformation and we’re looking for talented, ambitious individuals to help drive meaningful impact across the business.

The Role:

The role is responsible for ensuring compliance across daily operations and services requiring Quality Assurance (QA) involvement. Primarily provide QA support for production activities, as well as Warehousing and Quality Control departments, ensuring that all stages of Good Manufacturing Practice (GMP) are in full compliance with the principles of Good Practice (GxP) guidelines and other regulatory requirements.

The QA Officer will also play a pivotal role in providing QA support in deposition decisions, and the release of intermediate and finished products through the review of batch documentation, Certificates of Analysis (CofA’s) and laboratory testing results.

This role will also support production Team leaders in achieving GMP compliance excellence, and promote Quality Culture within the business. The QA Officer will manage the customer complaints process ensuring that product quality issues are investigated, escalated (where appropriate) and CA/PA implemented in compliance with worldwide regulatory requirements for Nelson’s products.

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 is kept within Quality Management System (QMS) and adheres to Data Integrity (see POL-002).
• Understanding and adhering to cGMP environment requirements.
• To oversee the management, implementation and maintenance of the QMS system to include regulatory updates
• To manage timely closure of CAPA, Change Controls, Deviations and Customer Complaints
• To write Standard Operating Procedures, approve production operating manuals, and maintain updated Standard Operating Procedures.
• To review Manufacturing batch records production documents to ensure all tasks performed are in keeping with GMP.
• Release of non-licensed products via the ERP System.
• Ensure all in-house manufactured, and third-party produced, finished products and associated documentation are retained promptly and accurately, and remain in an inspection-ready state.
• To ensure production anomalies are reported to QA Management via Deviation documentation or a ‘Quality Incident Report’.
• Escalate significant quality complaints or deviations that may require product recall assessment (or other action) to senior QA Management
• To coordinate the prompt investigation, resolution and/or closure of change controls, deviations, customer complaints and QIRs raised within your area of responsibility, in conjunction with other departments and provide reports and recommendations as necessary
• Remain up to date with actions and SOPs via both electronic and paper-based QMS systems
• Management of the Customer Complaints Process
• Ensure processes are in place and in use with Nelsons subsidiary offices and distributors to capture all customer complaints
• Trend customer complaints from across the Nelsons business and prepare data and KPIs for presentation at management review ensuring adverse trends are escalated
• To review decisions for investigating product complaints, and review and approve the findings and follow-up action of any investigation performed.
• Support the internal and external audit schedule to verify and monitor the applied principles of GxP.
• Support vendor management activities including vendor audits, QTA’s, vendor questionnaires.
• Support validation activities.
• To provide advice, guidance, and training where required to employees relating to QA to ensure a full and thorough understanding of GMP on-site.
• To own and implement improvement projects across the site that increase Quality compliance
• Complete Product Quality reviews for the selected time period
• To assist in Quality KPI's to monitor quality performance across the business.
• To work closely with all staff on site and especially production staff to ensure a good quality culture and openness
• To provide support to the daily operation staff regarding quality decisions
• To work closely and liaise with QP and Quality management to ensure any information regarding quality and production is completed in a timely manner