QA / Quality Assurance Audits and Inspections

**QA / Quality Assurance Audits and Inspections Specialist**who has significant experience working for a scientific technical area with excellent knowledge of cGMP and a good understanding of data integrity is required for a well-establishedcompany based in Abingdon, Oxfordshire.

**SALARY**:starting from £34,000 per annum

**LOCATION**:Abingdon, Oxfordshire

**JOB TYPE**:Full-Time, Permanent (This role may involve travel for supplier audits - it is primarily office based)

**JOB OVERVIEW**

We have a fantastic new job opportunity for a QA / Quality Assurance Audits and Inspections Specialistwho has significant experience working for a scientific technical area with excellent knowledge of cGMP and a good understanding of data integrity.

Working as a QA / Quality Assurance Audits and Inspections Specialist you will be required to take ownership of Supplier Quality, including the qualification of suppliers and support the process for any other suppliers requiring qualification for other companysites, as and when needed.

As a QA / Quality Assurance Audits and Inspections Specialist you will liaise with members of other departments to ensure timely and successful completion of tasks and provide advice to ensure their compliance to company policies, best practice and cGMP.

**DUTIES**

Your duties as a QA / Quality Assurance Audits and Inspections Specialist will include:

- Performs activities related to regulatory inspections and customer audits of the Oxford site, including backroom support, assisting with audit responses
- Own/approve key performance indicators such as deviations, change controls and CAPAs
- May deputise for the Audits and Inspections Manager
- Provide advice to other departments to ensure their compliance to company policies, best practice and cGMP
- Ensure completion of assigned deliverables on time and in full
- Liaise with members of other departments to ensure timely and successful completion of tasks
- Liaise with customers on matters of Quality (internal and external, all levels)
- Actively promotes Quality Culture across the site
- Promotes and contributes to continuous improvement
- Approval of non-compliance investigations (e.g., deviations, OOSs, etc )
- Approval of CAPAs and Change Controls. Work with all required departments to ensure that CAPAs that are raised as a result of any audit/inspection non-conformity are SMART and that CAPAs are closed by the due dates (for activities within QA control. Foractivities that involve other departments, support where possible to help ensure the timelines are met)
- Prepares, Reviews and Approves Quality related documentation
- Ensures that all required quality documentation is approved/reviewed on time and in full
- Identify opportunities for GMP compliance training and awareness
- Applies GMP regulations consistently and uses knowledge of GMP and quality processes to actively identify, suggest and participate in continuous improvement activities
- Provides the required support during client audits and regulatory inspections
- Maintains and updates personal training record
- Supports the Quality team as required

**CANDIDATE REQUIREMENTS**
- BSc or higher in a scientific area or equivalent
- Supplier Quality experience
- Lead Auditor certified to ISO 9001, or Pharmaceutical Quality Systems (preferred)
- Lean six sigma trained
- Excellent communication skills
- Excellent time management/organisational skills
- Significant experience working for a scientific technical area and for QA
- Excellent knowledge of cGMP
- A good understanding of data integrity
- Creative, innovative, proactive and dynamic
- Able to work as part of a team and also independently
- Able to suggest innovative and practical ideas/solutions to problems
- Exhibits professional behaviours at all times, is reliable and trustworthy

**APPLY TODAY**

JOB REF: AWDO-P8362

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