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Qualified Person

We are currently looking for a Qualified Person (QP) to join a Pharmaceutical company based in the Essex region.

As the Qualified Person, you will be responsible for the set up, maintenance and inspection-readiness of site Quality Systems, in accordance with regulatory guidelines.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Qualified Person will be varied however the key duties and responsibilities are as follows:

1.

You will be heavily involved with the design and implementation of Quality Systems, working with various sites, including manufacturing, warehousing and distribution.

You will be tasked with ensuring that the sites are inspection-ready in accordance with all aspects of GxP.

2.

You will provide support for all aspects of GxP compliance, including Auditing, Gap Analysis, Validation and will provide training to staff on aspects associated with these.

This will include visiting different international sites.

3.

As the Qualified Person, you will be working with internal and external customers, and will provide support with regulatory inspections, utilising your knowledge and expertise.

4.

You will participate with batch release and recall procedures as well as provide support with customer complaints.

ROLE REQUIREMENTS:

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.

Previous experience as a named Qualified Person.

Commercial release experience is essential, IMP release is desirable.

2.

As the Qualified Person, your past experiences will have given you exposure to varying dosage forms.

Exposure to different environments such as R&D, Production, Regulatory would also be highly beneficial.

3.

Prior auditing experience is required.

Key Words: Qualified Person | QP | Batch Release | Quality Assurance | QA | Quality Manager | Quality Systems | Audit | GxP | Regulatory | MHRA | International | Validation | QMS

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.