Provide QA support and oversight, aid in the implementation, maintenance and continuous improvement of the Quality Management System in line with cGMP. Work cross functionally with all departments to assure GMP standard and practice compliance, provide training and assistance as necessary.
* Provide QA oversight to the manufacturing operation and support functions ensuring compliance with EU, UK and US cGxP regulatory requirements, QMS and any other applicable regulations/standards.
* Work with the QA team to support a "Quality on the Floor" culture, perform facility walk arounds to maintain a high level of compliance and QA oversight by working closely with operations ensuring proactive approach to identify potential issues and minimise impact.
* Perform (plan, execute, follow-up) self-inspections in a timely manner to schedule.
* QA review and approval of quality documentation generated, including but not limited to Deviations, CAPAs, change controls, risk assessments and OOO/OOT.
* Deliver GxP compliance training to operational areas.
* Generate and prepare Quality controlled documents (e.g. SOPs) and Training Material.
* Provide QA review of controlled documents as applicable, including but not limited to SOPs, Forms, Templates, Logs and Manufacturing Batch Records.
* Aid in the management of and proactively initiate/support continuous improvement of the Quality Management System.
* Support the preparation, execution and follow-up of regulatory inspections.
* Ensure own work complies with GMP, Data integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents e.g. SOPs, BMRs, Protocols.
* Ensure own training is undertaken in a timely and GMP compliant manner before the task is undertaken.
* Ensure own and QA KPIs, plans, targets and objectives are effectively tracked, monitored and achieved.
* Experience working in a GxP environment including a minimum 3-5 years' experience in Compliance and Quality Assurance.
* Experience of working within a sterile GMP manufacturing environment.
* Good understanding of GMP requirements and Quality Management Systems.
* Experience identifying and escalating issues to line management, to ensure workload is prioritised, issues are highlighted to ensure business needs are met. Proficient in Microsoft Office and experience in database use and eQMS systems.
* Good organisational and time management skills and able to demonstrate flexibility and adaptability.
* Able to prioritise workload, decisive thinker able to work within agreed timescales. Communicate with the team issues and/or potential rate limiting factors where encountered.
* Knowledge of GCP and GMP with regards to QMS activities
* Experience with regulatory body inspections and audits.
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