- Experience Level
Hobson Prior are seeking a QA Manager to join one of the largest independent short-line pharmaceutical organisation where you will be accountable to lead the QA department and monitor performance against departmental KPI's. This opportunity will be located in either Watford or London a permanent basis.
- To lead the QA team ensure the departmental KPI's are met.
- To provide a monthly report to the Head of QA/QP on the status of the QA teams activities in relation to KPI's and QMS activities.
- To advise the Head of QA/QP of potential issues in other departments that may directly impact the QMS.
- To assist the Head of QA/QP where required including but not limited to the following:
- To update and approve the Standard Operating Procedures - and where required author new SOP's.
- Updating and maintaining all QA tracking tools / logs to allocated activities.
- Completing Product Quality reviews related to allocated projects in a timely manner.
- Carrying out/Assisting with internal audits as required.
- Identifying and investigation into Deviations/Complaints/Supplier Complaints in a timely manner.
- Monitoring and ensuring CAPAs are implemented in a timely manner.
- Assisting with product recalls.
- Review and respond to Change requests, Deviations and CAPA's from CMO's in a timely manner
- To liaise internally with relevant QP's to ensure regulatory requirements are assessed and documented.
- To liaise with the organisation's Regulatory team to ensure variations are submitted in a timely manner
- Ensure "Product licence" folders are maintained.
- Filing and archiving of all Quality-related documents.
- Mentoring an allocated member of the QA team.
- Participate in both internal and external audits as required.
- To chair, on rotation, the Quarterly QMS.
- Good interpersonal skills.
- Ability to build a team.
- Hold a suitable degree in a scientific subject.
- Membership of an appropriate professional body.
- At least 5 years' experience in a GMP/MIA environment.
- Competence in Microsoft Office.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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