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We are currently looking for a QA Specialist to join a leading Pharmaceutical company based in the Oxfordshire area. As the QA Specialist, you will be responsible for maintaining cGMP compliance across the business function.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the QA Specialist will be varied. However, the key duties and responsibilities are as follows:
1. You will represent the QA department across multiple business areas, interacting with the QC and Validation teams. You will demonstrate a complete understanding of cGMP procedures, and put them into practice.
2. As the QA Specialist, you will monitor Quality KPI's, identify trends, lead investigations and resolve any issues with your line manager. This will involve generation and review of QA procedures and other documentation, as well as supporting root cause analysis and driving CAPA implementation.
3. It will be your responsibility to participate in and lead internal and external audits/inspections, seeking continuous quality improvement across the site.
4. As the QA Specialist, you will provide GMP training to your colleagues, maintain an on-site QMS, produce batch manufacturing records, and conduct in PQR's to keep the business and products GMP compliant.
To be successful in your application to this exciting opportunity as the QA Specialist, we are looking to identify the following on your profile and history:
1. Proven industry experience in Quality Assurance, with previous time spent working with API/Biologic's products.
2. A working knowledge and practical experience with GMP requirements, additional experience with equipment validation would be highly advantageous.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors and is made up of a collaboration of scientists supporting science. We look forward to helping you with your next career moves.