Quality Assurance Specialist

**Quality Assurance Specialist**with a BSc or higher in a scientific area and good knowledge of cGMP and other regulatory requirements who is creative, innovative and dynamic is required for a well-established pharmaceutical company based inAbingdon, Oxfordshire.

**SALARY**:Starting from £30,000 per annum (Dependent on experience) + Bonus + Excellent Benefits

**LOCATION**:Abingdon, Oxfordshire

**JOB TYPE**:Full-Time, Permanent

**WORKING HOURS**:40 hours per week, with no nights or weekends

**JOB OVERVIEW**

We have a fantastic new job opportunity for a Quality Assurance Specialist with a BSc or higher in a scientific area and good knowledge of cGMP and other regulatory requirements who is creative, innovative and dynamic.

Working as a Quality Assurance Specialist you will participate in the improvement, update, alignment and maintenance of the existing quality system processes, procedures and related tools (Change control, deviations, CAPA, Validation, Qualification, RiskManagement), so that these reflect the last updated guidelines, best practices and standards.

As a Quality Assurance Specialist you will lead Quality Systems improvement projects across the site and be responsible for decisions related to GMP compliance in relation to the work, dealing with the challenges associated with a multi-client driven business,and require the energy and enthusiasm to play a contributory part in a diverse team.

**DUTIES**

Your role as a Quality Assurance Specialist will include:

- Support the implementation and management of new and existing Quality IT systems (eDMS, eQMS), from a CSV and Key User standpoint
- Responsible for the maintenance of the Quality IT systems (eDMS, eQMS), from a system owner standpoint
- Support the implementation of new and existing IT systems (LIMS, MES, ERP) from a CSV standpoint
- Promote and contributes to Continuous improvement activities
- Aid in the identification of inefficient processes and introduction of lean alternatives whilst maintaining compliance
- Ensure activities within the area are aligned with the company policies, best practices and are cGMP compliant
- Involved in the assessment and optimization of the quality processes, aiming for better and streamlined processes and updating the related procedures and tools accordingly
- Contributes and participates in the validation of computerized systems as a QA reviewer/approver
- Assures that all maintenance activities required for the Quality IT systems (eDMS, eQMS) are performed as expected
- Supports the site users regarding any queries related to Quality IT systems (eDMS, eQMS)
- Provides the required support during client audits and regulatory inspections
- Liaise with members of other departments to ensure timely and successful completion of tasks/projects
- Liaises with members of other departments at all levels to resolve any Quality related issues
- Provide advice to other departments to ensure their compliance to company policies, best practices and cGMP
- Work with Quality & GMP training group for the preparation of the related training for the new/revised quality processes/tools/systems required for the users

**CANDIDATE REQUIREMENTS**
- BSc or higher in a scientific area
- Lean six sigma training (preferred)
- Project Management skills (preferred)
- Strong communication skills with the ability to interact with all levels throughout the organisation
- Excellent time management/organisational skills
- Experience working for a technical area and for QA
- Experience in computerized systems validation
- Good knowledge of cGMP and other regulatory requirements (ICH, EU, CFR), how they relate in the larger regulatory environment and an ability to place them in context
- Sound Data Integrity knowledge/experience
- Excellent teamwork in cross-functional environment
- Creative, innovative, proactive and dynamic
- Able to suggest innovative and practical ideas/solutions to problems
- Excellent interpersonal skills
- Excellent critical thinking, the ability to risk assess problems and prioritise actions according to risk, and Root Cause Analysis
- Ability to work independently as and when required

**APPLY TODAY**

JOB REF: AWDO-P9068

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