Quality Assurance Officer

4 months ago

Wimbledon, United Kingdom Nelsons Full time

The role is responsible for ensuring compliance across daily operations and services requiring Quality Assurance (QA) involvement. To primarily provide QA support for production activities, but also to Warehousing and Quality Control departments, and ensure that all stages of Good Manufacturing Practice (GMP) are in full compliance with the principles of Good Practice (GxP) guidelines and other regulatory requirements. To provide 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. To support production Team leaders in achieving GMP compliance excellence, and promote Quality Culture within the business. To 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.

Key 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

**Requirements**:

- Experience in a QA/QC role in either food or Healthcare
- Knowledge and practical experience of GMP
- Good knowledge of Quality Control Laboratory techniques, necessary for review.
- Numerical, analytical and investigative skills
- Strong interpersonal and communication skills
- Ability to work accurately, with attention to detail
- Ability to prioritise and deal effectively with a varied workload

**Bonus if you have**
- 3+ years’ experience within a GMP environment
- Ability to form strong working relationships with stakeholders at all levels across the organisation

**Benefits**

Annual bonus

25 days holiday per year PLUS Christmas shut down - whoop

Free products and staff discounts to keep you healthy and happy
- 3pm Friday finishes ALL YEAR ROUND (if you have done your work, obvs)

Hybrid and flexible working

✨ Paid days off to

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