Quality Assurance Specialist / Wales

Quality Assurance Specialist

The client is recruiting for a Quality Assurance Specialist to join an established innovative biotechnology company that is based in Deeside. They are offering £30,000 - £45,000 DOE, private medical cover plus benefits. This company has recently had a large amount of investment with plans to massively extend the size of the site due to this, so it is a fantastic time to join this business.

This role is reporting directly into the Quality Assurance Manager and is responsible for ensuring there is adequate QA support for production activities (including batch review), oversight of material management and approval of materials / service providers, approval of validation documentation and maintaining the quality management systems.

Key Responsibilities:

• Assisting in the setting up of the quality management system, document management, templates and compliance activities
• Establishing and presenting Quality Management Systems metrics to the site leadership team to promote continuous improvement
• Support during customer and regulatory audits
• Supporting the review of all batch related documentation
• Supporting quality related investigations
• writing investigation reports and initiating/following up on corrective and preventative actions
• Leading Quality based projects
• Approving pre and post execution validation documents
• Supporting material management processes to ensure materials are of the correct quality and are sourced from approved suppliers
• Supporting batch release of clinical and commercial bulk drug substance / API against product specification files.
• Ensure that all stages of Good Manufacturing Practice (GMP) are in full compliance with the principles of Good Practice guidelines and other regulatory requirements.
• Perform self-inspection audits, and ensure any deficiencies are highlighted and then adequately mitigated

Skills and Qualifications:

• HND Biological subject or in excess of 5 years working within a Quality Assurance department.
• Minimum 3 years’ experience in a QA or QC role within either Pharmaceuticals or Biopharmaceutical environment.
• Experience using Microsoft Office suite of programs
• Knowledge and practical experience of GMP & GLP
• Numerical & investigative skills
• Ability to work accurately, with attention to detail
• Ability to prioritise and deal effectively with a varied workload
• Good communication skills with the ability to form strong working relationships with stakeholders at all levels across the organisation.
• Approachable and friendly, with the confidence to challenge results and performance when required.