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