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We are currently looking for a Qualified Person QP to join a Pharmaceutical manufacturing site based in the Kent area. As the Qualified Person you will be responsible for ensuring that all products released comply with regulatory and quality standards.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Qualified Person QP will be varied however the key duties and responsibilities are as follows:
1.You will be named as the Qualified Person on the companies manufacturing and wholesale dealers licenses as required by article 51 of Directive 2001/83/EC and Article 55 of Directive 2001/82/EC. This opportunity will allow you to release multiple dosage forms.
2. As a Qualified Person, you will form a part of the Senior Quality Leadership team, advising on the strategy of the Quality department. This will include working with the sites Senior Leadership Team, advising on Quality standards and developments.
3. Alongside the batch release procedures, you will be tasked with supporting the management and development of the site wide Quality Systems (QMS). You will be very visible throughout the site, and will be a visible person on the manufacturing floor, advising other staff on QA regulations.
4. You will lead regulatory audits on site. This will include meeting with the MHRA, the FDA and the EMA and you will work to enhance the Quality reputation of the business.
To be successful in your application to this exciting opportunity as the Qualified Person QP we are looking to identify the following on your profile and past history:
1. You will be recognised as a Qualified Person with previous batch release experience.
2. Along with being a QP, you will ideally have experience either managing a Quality function or Quality systems.
3. Previous experience working with any of the MHRA, the FDA or the EMA is essential.
Key Words: Qualified Person | QP | Quality Assurance | Quality Operations | Batch Release | MHRA | FDA | EMA | QMS | Quality Systems | Dosage Form | Release
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.