We are recruiting for a Quality Specialist to join a growing Pharmaceutical business and play a key role in the company's continued growth.
About the business:
This organisation is well established, has a diverse customer base, and is well geared for growth in the coming years. The business supplies a range of pharmaceutical products into multiple segments of the healthcare sector and has a strong reputation as one of the leaders within this field.
They have a diverse and inclusive team, and you will get the opportunity to work alongside a talented Quality team to play a key role in driving a positive quality culture.
About the Quality Specialist role:
The Quality Specialist will be responsible for administration and database control within the department. You will provide administrative support to customers and colleagues while being responsible for maintaining databases such as error recording, enquiries, final release, CAPA, and QMS.
The scope will also include overseeing the quality of all products manufactured or sourced by the company and ensuring adherence to GMP, GDP, documented procedures, and work instructions.
Some of the key responsibilities for the Quality Specialist will involve the following:
1. Promoting Quality Compliance (GMP) within the site and complying with company policies.
2. Reviewing Finished Batch Record and GMP Release for final QP Release.
3. Overseeing and inputting to QMS related Change Control, Non-conformance, and CAPA's.
4. Developing, enhancing, and updating the Quality Management System (QMS) activities associated with the release of product, integrating as appropriate into central activities.
5. Ensuring appropriate maintenance of filing of Quality related documents, including Deviations and CAPA's.
6. Maintaining all QA databases which include but are not limited to QMS, master list, quality metrics, errors, daily orders, product enquiries, and documents.
7. Supporting in product enquiries ensuring timely responses.
8. Controlling and maintaining Quality documentation, including generating, reviewing, and issuing SOPs, forms, and BMRs.
9. Liaising with suppliers in order to obtain documents needed for Quality Approval such as leaflets, cartons, and licenses.
10. Writing documentation including reports, recording deviations, non-compliances, and other quality related forms.
11. Coordinating and managing to resolve customer complaints, recalls, change controls, ensuring proper root cause analysis and prompt responses/resolution.
The successful candidate for the Quality Specialist role will have the following background:
1. Prior experience working in a Quality function, as a Quality Specialist / Quality Officer within the Pharmaceutical industry.
2. A Scientific Degree Qualified, along with credible industry relevant training.
3. Batch release experience is highly desirable.
4. Good understanding of Good Manufacturing Practice (GMP).
5. A team player, who enjoys working with others to drive positive change within a complex environment.
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