Quality Assurance Specialist

Quality Assurance Specialist focuses on performs batch review within the designated timelines described in departmental kpi.

What the role involves

• Performs batch review within the designated timelines described in departmental KPI.
• Support the completion of actions through liaison with other departments.
• Review for completion “other” category CA/PA.
• Assists in the performance of supplier audits, supporting the Lead Auditor.
• Acts as a support to client and regulatory audits, helping with technical support to the audit team and responding to requests for documentation and information.
• Audits to ensure compliance with Quality Management System procedures and GMP regulations.

Skills and requirements

• This role involves a high throughput of documents and information to process.
• Hold a Science related qualification, degree or a minimum of HND level with QA experience.
• Have proven experience within a similar Quality manufacturing environment.
• Have a clear understanding of regulatory commitments, e.g. GMP, ICH, COSHH as well as practical experience of GMP procedures, facilities and methods.

Confirmed role details

• Curia is a leading global provider of advanced drug development, contract research and manufacturing solutions to the pharmaceutical and biotechnology industries.
• 37.5 (flexible start/finish times).

Candidate fit

• technical problem-solving, careful delivery, documentation discipline, and clear communication with stakeholders

Additional role context

• Reviews Type 1 change controls, and green category deviations. Provides feedback.
• Works to a schedule as defined by the Quality Manager.