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We are currently looking for a Qualified Person (QP) to join a leading biologics company based in the Oxfordshire area. As the Qualified Person you will be responsible for ensuring that Investigational Medicinal and Commercial products are manufactured in accordance with GMP regulations.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Qualified Person will be varied however the key duties and responsibilities are as follows:
1. Serving as the Qualified Person (QP) you will certify batch releases in accordance with 2001/83/EC, 2001/20/EC.
2. You will support the Senior Leadership team with the management and development of the Quality Assurance team and site wide Quality Systems. You will help guide the changes and developments needed with updated regulations, such as the Falsified Medicine Directive.
3. As the Qualified Person (QP) you will help guide and coach the Quality Assurance team, having an input on Quality policies, objectives, deliverables and strategy.
4. You will be tasked with participating and working with external customers and technical groups to assist in keeping the business up to date with the latest regulations. You will therefore become the SME on Quality for the business.
To be successful in your application to this exciting opportunity as the Qualified Person we are looking to identify the following on your profile and past history:
1. Because of the site wide visibility and interaction you will have from this position, we would like to see experience across different disciplines including Validation and Quality Assurance. Experience developing and/or implementing a QMS would also be beneficial.
2. You must be a Qualified Person as you will be tasked with releasing both IMP and Commercial batches. You must have had prior experience releasing commercial batches as this is the preference. IMP release is highly desirable.
3. Prior experience coaching and developing QA staff is essential. Your input in assisting the teams development is essential.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We 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 recruitment processionals and scientists. We look forward to helping you with your next career moves.