Life Sciences Pharmaceuticals
An excellent opportunity has come up for an experienced QA Specialist to join a global pharmaceutical leader at their site in Stevenage. On an initial 6-month basis, the QA Specialist will ensure that the Biopharmaceutical testing laboratories comply with all QMS and relevant regulatory standards in relation to data generation and laboratory testing and approval.
The QA Specialist will be responsible for:
- Initiate and coordinate deviation and change control notifications in the SAP system, complete CAPAs and change control tasks as required, participate in root cause analysis for deviations, customer and service complaints as QA representative as well as performing department’s self-inspection and Audit Trail reviews, maintaining associated schedules and documentation.
- Ownership of quality systems (e.g. deviations, change controls), Control Printing, Reconciliation Process and site Curricula Review Process; including provision of metrics and report program trends on a periodic basis and review and initial approval of LI notifications in SAP system.
- Manage the archiving for all documentation both on and off-site. This includes maintaining the validated document register, organizing and filing paperwork in line with local procedures and requirements, as well as retrieving and returning archived documentation as required.
- Assist in the preparation for and participation in regulatory agency inspections, corporate, customer and monitoring L2 audits including audit readiness assessments as required.
- Provide support to the site Compliance team by performing activities such as; review and respond to Quality Alerts, maintenance of the GMP training schedule.
- Perform CDMS Local Administrator role for CDMS and support the lab as the site contact for GMS CDMS and provide training for CDMS as required.
- Manage the lab Records Retention Schedule and act as Records Champion.
- Compete administration activities as required.
This is a great opportunity for an experienced QA professional looking to join a global leader, if this sounds like the opportunity for you, apply with your CV now. Feel free to contact Tom Kirkpatrick at CY Partners for more information.