Due to continued growth, a pharmaceutical company requires an experienced QA Officer to join its team. Your role will be to support a small QA team with the development, maintenance and continual improvement of the Quality Management System and quality policies. You must have previous experience working in a QA function in another pharmaceutical business.
The role reports to the Head of QA and the key responsibilities include:
* The development, maintenance and continual improvement of the Quality Management System (QMS) and Quality Policy ensuring compliance to quality standards & regulations, in particular GMP, GLP, GCP and UKAS/ISO17025.
* To work in compliance with the Company Policies including in-house Health & Safety and GMP, GLP, GCP and UKAS quality requirements.
* Providing support (mentoring/coaching) to junior operational staff.
* Ensuring the continual quality improvement in working practices and a strengthening of the company's quality culture by:
1. Production, development and maintenance of quality policies, procedures and documentation to ensure compliance to quality regulations and good working practices throughout the organisation
2. Provision of guidance and assistance in quality related issues to the staff including training and the monitoring of training records and their effectiveness
3. Performing internal inspections, both scheduled and unscheduled
4. Inspecting plans, analytical phases and reports for projects including those requiring GLP or GCP compliance
5. Measuring and monitoring the effectiveness and compliance of the QMS through the output of internal and external audits and other investigations
6. The application and follow up of appropriate corrective and preventive Actions (CAPA) where required
7. Providing a point of contact for quality related issues for both internal and external communications and supplying client liaison in general
8. Hosting audits from clients & regulatory/accrediting bodies
9. Ensuring that controlled documentation is reviewed and issued in a timely manner and reflects both current and valid practices
10. Performing supplier approvals which may involve external audits of supplier facilities
* Previous experience in a QA role including:
- the creation, review/approval of deviations, OOS investigations and CAPA
- root cause analysis / problem solving
- hosting client audits and performing internal audits
- change control processes
- review/approval of validation protocols and reports
- the use of an eQMS
- Quality Metric Trending
* The ability to work alone and as part of a team,
* Have an appetite for continuous improvement initiatives,
* Be comfortable managing conflict and dealing with customer complaints
- Good Manufacturing Practices
- Quality Management Systems
- Corrective And Preventive Action (Capa)
- Product Quality Assurance