17 Jun Quality Control Analyst Medior
We are seeking applications for an experienced Quality Control Analyst Medior to join our client, who are a Fortune 500 International company at their manufacturing facility based in Norfolk.
Why you should apply:
- This is a fantastic opportunity to join a diverse, high-performing team that are engaged and innovative, and whose mission it is to save and sustain lives. Their innovative products and therapies can be found throughout hospitals and clinics as well as patients’ homes internationally.
What you will be doing:
- Inspect and release final products as per Company policies
- Provide QA oversight to validation and product, documentation and process changes
- Ensure that a schedule of environmental monitoring is in place that complies with GMP and that any out of limits or alerts are investigated and actions taken to correct
- Investigate out of limits results;
- Ensure that all measuring equipment that may have an impact on product quality is calibrated to traceable standards through its life cycle, using the electronic equipment management systems and related tracking sheets;
- Review and approve planned and unplanned work.
- Support QC Officer with raw material testing, release and Quarantine area issues, where required
- Support supplier complaints, managing samples for evaluation and investigation results, and liaise with Central Supplier Management teams to address and resolve issues.
- Ensure product complaints are adequately investigated and appropriate corrective and/or preventative actions are implemented
- Support QA Supervisor in the management of escalation forms, product holds and Field Actions;
- Report any adverse events to Pharmacovigilance and to Business management representative.
- Monitor all Quality System processes to identify improvement opportunities
- Manage of the deviations system using Trackwise software
- Ensure deviations investigations are completed, assignable causes and/or root cause(s) are identified and that appropriate actions are specified and completed according to agreed time frames
- Facilitate the implementation of an ‘Audit Ready’ complaint site which is always ready for MHRA, corporate, internal or 3rd party audit
- Support the completion of audit findings and fully investigate to find the root cause and actions to address the audit findings are carried out in a timely manner.
- Provide daily guidance to production personnel to ensure compliance with GMP standards and local requirements are met at all times
- Regularly communicate with all site staff quality issues and promotes the Quality System as a business process for improvement of customer satisfaction and regulatory compliance;
- Ensure staff understand their responsibilities under the Quality System regulations;
- Communicate changes of the Quality System to staff; ensuring appropriate training programs are executed.
- Support EMS initiatives (e.g. 6S audits, tier board attendances, GEMBA walks) and maintain own Leader Standard Work
- Identify wastes and propose Kaizens at relevant forums.
What you need to apply:
- Pharmacy qualification/equivalent in science. CHND level or above, BTech or degree.
- 2 years post qualification work experience
- Life science experience is a plus but not a requirement.
- Methodology: Aseptic manufacturing / tech & clean room tech is an advantage.