Qualified Person

North West England
£65000 to £75000 per annum
03 May 2019
31 May 2019
Chris Carey
Contract Type
Full Time
We are currently looking for a Biologics Qualified Person (QP) to join a leading global life sciences company based in the North West area. As the Biologics Qualified Person (QP) you will be responsible for undertaking the duties of a Qualified Person as defined in Directives 2001/83/EC as amended and 2001/20/EC, in addition to the reviewing of relevant documentation associated with the manufacture and testing of Drug Substance and Drug Product Intermediates; all within a GMP environment.


Your duties as the Biologics Qualified Person (QP) will be varied however the key duties and responsibilities are as following:

1. Conduct QP certification of Drug Product Intermediates in accordance with UK Code of Conduct for Qualified Persons, alongside recording batches of biologics released in the QP Register; ensuring that all processes and procedures that are required for QP certification and batch release of drug substance are fit for purpose. This would require working with the Principle QP to maintain and improve all activities directly and indirectly related, and acting as a point of contact for any queries.

2. Act as a GMP Subject Matter Expert (SME) to facilitate site compliance with the company's Pharmaceutical Quality System (PQS); whilst supporting senior QA leadership through QP decision making to drive continuous improvement and fitness for purpose' especially with both regulatory and customer audits of the site.

3. Record items of CPD in line with requirements, actively developing, mentoring, training and enforcing a site GMP culture. Utilising knowledge of GMP and quality processes to advise non-QA functions on compliance issues whilst supporting Senior Quality Associates and QA (Operations) Team Leader roles when needs dictate.

4. Manage assigned areas and engage in self inspection of the site QMS with full ownership for maintaining compliance status, supporting site QA leaders and other QPs with information to support site QMS management, decision processes and strategy development


To be successful in your application to this exciting opportunity as the Biologics Qualified Person (QP) we are looking to identify the following on your profile and past history:

1. Relevant degree in a Science or QA discipline and registered as a Qualified Person (QP)

2. Proven industry experience gained as a QP on a manufacturing licence in the release of biologics as well as QMS process design, implementation, management and utilisation experience

3. A working scientific knowledge and practical experience with GMP, with the ability to interpret and translate GMP guidelines into effective processes and procedures

Key Words: QP / Qualified Person / Biologics / GXP / GMP / QA / Quality / Quality Assurance / QMS / Audits / Auditing / Batch Release / Directives 2001/83/EC / Directives 2001/20/EC / Quality Management

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.