Responsible for ensuring that the technical processes meet the best in class Quality standards through provision of Quality support to Technical Operations ensuring a high standard of awareness, understanding and compliance of Quality SOPs and processes.
Quality Management System
- Develop, enhance and maintain the Quality Assurance programme to meet best in class standards.
- Enhance the regulatory understanding and capability of the team
- Ensure the organisation meets its statutory obligations in all Quality areas and supports the fostering of a workplace which focuses on 'right first time'.
- Ensure all SOPs, forms, logs, protocols and summary reports are completed and reviewed against Quality standards. Issue laboratory notebooks and equipment logbooks as required.
- Support the development and implementation of QMS programme across the organisation.
- Identify and implement training to ensure efficient and effective completion of all Quality related training.
- Ensure that all quality SOPs and programmes are adhered to and are regularly reviewed, updated and communicated.
- Prepare Quality compliance metrics as required.
- Ensure that all CAPAs and deviations are documented, investigated and recommended improvements implemented.
Audit Readiness & Continuous Improvement
- Provide subject matter expertise to Technical Operations on various Quality related topics.
- Support any external Quality audits with co-ordination of audit activities and action plans.
- Conduct internal Quality audits e.g. walk through audits, system audits, report issuance, CAPA follow-up and closure. Ensure that follow-up actions are completed.
- Ensure compliance of Quality and use analytics to measure compliance across the organisation.
- Establish a structured programme of Quality training across the organisation and ensure accurate training records are maintained.
- Facilitates 'as is' mapping and root cause analysis. Use continuous improvement tools to instigate actions for improvements.
- Adhere to business processes as required.
Collaboration & Engagement
- Provide Quality oversight for assigned projects within Technical operations. Actively participate in projects by attending meetings (internal and external) and project updates, perform quality review of laboratory notebooks, technical data and the final technical reports
- Contribute to and participate in the After-Action Review (AAR) meetings.
- Prepare and deliver quality training materials to colleagues.
- Share information, suggestions and observations to create consistency in Quality standards across the organisation.
- Collaborate with HR and Training on LMS and training activities.
- Participate in relevant forums e.g. QMS/SMS, training, equipment as required to improve awareness of Quality
- Required: Degree level or equivalent in life sciences.
- Desirable: Inclusion of Quality related subject in qualification.
- 3-4 years' experience working in the pharma/biopharma industry or R&D environment.
- Good working knowledge of implementing and using continuous improvement tools.
- Experience with implementation of corrective action programmes.
- Experience of development, implementation and management of Quality Management systems.
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