QA Specialist

Please find a link to our corporate video for a quick insight into Valneva

Please find a link to our corporate video for a quick insight into Valneva

Our IT team are currently recruiting for a **System Engineer/ Validaton Specialist **to assist in developing and maintaining a comprehensive quality management system to achieve inspection readiness. Additionally, act as Quality Assurance support for Valneva’s distribution network.

**Requirements**:
Develop, monitor, improve and maintain procedures to ensure compliance with EU/FDA Good Manufacturing Practice for the manufacture and testing of pharmaceuticals

Develop, monitor, improve and maintain procedures to ensure compliance with EU Good Distribution Practice for pharmaceutical products

Perform activities and reviews in accordance with relevant Standard Operating Procedures, including but not limited to:

- Quality Investigations
- Review of Documentation
- Batch Review (including PPRs, SPRs, MPRs, QC Test Records)
- In-Process Inspections
- Room Release
- Facility Release (OB1)
- Protocol Discrepancies
- Label checks
- Batch Release
- Lot Release Protocols
- Authorisation to Label & Pack
- Final Authorisation to Distribute
- Batch Review (including PPRs, SPRs, MPRs, QC Test Records)
- In-Process Inspections
- Room Release
- Facility Release (OB1)
- Protocol Discrepancies
- Label checks
- Batch Release
- Lot Release Protocols
- Authorisation to Label & Pack

Perform batch review duties in accordance with relevant procedures, including issuing Certificates of Non-Conformance for bulk drug product and review of QC batch test folders

Identify, investigate and report quality issues, escalating to management as required

Participation in cross-functional projects

Develop, implement and monitor Continuous Improvement activities

Provide QA coaching / guidance for cross-functional groups to ensure compliance with KPI targets including functional QA if required

Co-ordinate and provide training across functional groups in Quality Procedures, cGMP requirements and QA concepts

Trend and report batch review and QMS data

Provide support to management during third-party audits

Perform internal housekeeping, in-process visits and quality audits

Perform external quality audits, supporting Livingston and other Valneva sites

Implement and maintain Quality Standard Operating Procedures, as required

Train staff in QA related procedures and concepts as directed by line manager

To undertake any other duties as requested by the line manager in accordance with company requirements.

**Experience**
- Educated to degree level in relevant qualification or relevant experience
- Proven and logical approach to problem solving
- Previous QA experience
- Experience working effectively in a team, influencing as appropriate
- Experience working within a GMP manufacturing environment
- Knowledge/experience of the requirements for distribution of pharmaceutical products

**Benefits**
- Stock Options
- Employee Assistance Programme
- Gym membership OR fitness allowance
- Free Fruit
- Many others included