We are currently looking for a Quality Specialist to join a leading pharmaceutical company based in the Berkshire area. As the Quality Specialist, you will be responsible for ensuring compliance with global and local procedures, policies, and regulations by applying the processes defined in the Quality Management System.
This is an initial 12 month contract and can offer hybrid working, 3 days p/w remote, 2 days p/w onsite.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Quality Specialist will be varied; however, the key duties and responsibilities are as follows:
1. As the Quality Specialist, you will support the execution and maintenance of the Quality Management System within the organisation, ensuring records such as Deviations, Change Controls, and Complaints are raised and processed in the relevant electronic system.
2. As the Quality Specialist, you will report identified gaps and propose potential Corrective and Preventative Actions, ensuring these actions are raised, tracked, and closed within target timelines.
3. As the Quality Specialist, you will track and trend quality system data and key performance indicators, preparing, reviewing, and approving batch documentation to ensure timely QA disposition of medicinal products on the market.
4. As the Quality Specialist, you will coordinate the stability program for local products, support the affiliate annual self-inspection program, and contribute to the periodic Management Review of quality systems and procedures.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the Quality Specialist, we are looking to identify the following on your profile and past history:
1. Relevant degree in Life Sciences (e.g. Biology, Chemistry, Pharmacy).
2. Proven industry experience in a pharmaceutical quality function.
3. A working knowledge and practical experience with Microsoft Office software such as Microsoft Excel, Microsoft Word, and Microsoft Outlook.
Key Words: Quality Specialist / Pharmaceutical Quality / Quality Management System / Deviations / Change Controls / Corrective Actions / Preventative Actions / Batch Documentation / Stability Program / Self-Inspection / Management Review
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.