Quality Assurance Specialist

Quality Assurance Specialist - Pharmaceutical/Medical Device - Hampshire, UK

Our client is a large CDMO manufacturing business, developing and producing Cosmetic, Nutritional, Pharma and Medical Device products from three production sites in the UK. They work with a variety of blue-chip, high-street retailers and brand owners across premium markets, producing globally marketed products. 

Reporting to the Quality Assurance Supervisor, the main purpose of this post is to ensure that any customer quality issues and consumer complaints are investigated and responded to in a timely manner. To support with investigations into non-conformities whilst ensuring that any corrective/preventative actions are effective and meet regulatory expectations, and to assist in the support of new product introduction.

The job holder will have a good knowledge of quality improvement tools and techniques and be an experienced auditor.
This is a hands-on role which will involve spending time on the production lines and some product inspection.


Key Duties and Responsibilities

• Co-ordinate the QMS internal audit programme including planning the audits, assigning the auditors, carrying out audits, ensuring audit reports are produced and signed off in a timely manner, ensuring corrective actions are logged.
• Support the operations team in carrying out investigations into internal non-conformities or quality issues -advise problem solving techniques that could be used to establish the root cause of the issue and identify appropriate corrective and/or preventative actions where applicable and in a timely manner.
• Manage the Change Control Process
• Investigate customer quality issues and consumer complaints and ensure that responses are provided in a timely manner.
• Review and complete Deviations in a timely manner- allocate actions to the QC department as applicable
• Attend customer meetings as required
• Monitor the corrective and preventative action (CAPA) process by ensuring proposed actions are relevant and applicable and by carrying out verifications on these actions.
• Carry out effectiveness checks on CAPAs.
• Assist in the review and update of Risk Assessments as required
• Support the new product introduction process by providing specific quality engineering expertise to NPI projects
• Participate in line trials. Present findings at post line trial run review meetings
• Oversee first production start-up of new products, including carrying out capability studies and product inspection to ensure that Customer specifications and requirements are achieved. Present findings at post first production run review meetings
• Review and sign off Packing Specifications
• Assist and support the Administration Team with completion of PQR reports
• Carry out any other reasonable projects and duties as determined by the Quality Assurance Supervisor or Quality Manager