Main responsibilities:

Operations are performed in accordance with cGMP using Virginia’s standard operating procedures and within the validated state

Production processes and areas are audit ready at all times

Quality Key Performance Indicators (KPIs) metrics are managed and communicated via department meetings and Quality Management Review

Quality behaviors exhibited by manufacturing, Engineering, Supply Chain and Quality and a culture of continuous improvement is fostered and aligned with cGMP

As Quality Assurance’s representative, be the first point of contact for any issue that may result in change to or deviation from a validated system or process that may impact product quality or safety

Through direct involvement with Production and Engineering Management ensure that work performed is as per approved standard operating procedures and GMP documentation.

Proactively identify continuous improvement opportunities; potential risks; and cGMP deficiencies to processes and documentation. Work closely with Production and Engineering to implement appropriate improvement or corrective measures.

Ensure non-significant deviations are closed within a timely manner. Support investigations and agreed actions are closed within expected lead-times.

The management of Product Technical Complaints and associated investigations

Participate in internal, and regulatory audits conducted by Quality and relevant regulatory agencies

Ensure that established Quality KPI’s are met, monitored, and communicated within Manufacturing, Engineering and Quality

In conjunction with Area Management ensure that responsible areas are in a state of readiness for regulatory and customer audits with all information readily available.

Perform the review/audit of batch records as per approved QA checklist.

Be responsible for the position of the Authorised Delegate for the market release of Virginia site manufactured product.

Review and approval of batch related documentation such as manufacturing formulas, instructions and specifications.

Review and approval of operational GMP documentation as needed