Qualified Person

Experience Dependent
Oct 14, 2016
Nov 11, 2016
Ricky Martin
Result Type
Position Type
Full Time
We are currently looking for a Qualified Person to join a leading company based in the Essex area. As the Qualified Person you will undertake the duties of a Qualified Person as defined in Article 51 of 2001/83/EC to deliver the timely release of products, as well as taking on management responsibilities for key quality operational based on prior experience (the role can be flexible based on experience and interest).


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

1. To undertake the duties of a Qualified Person as defined in Article 51 of 2001/83/EC
Deliver timely release of products, ensuring that the product is fit for its intended use, complies with the requirements of the relevant Manufacturing License, the Marketing Authorisation (MA) and does not place patients at risk due to inadequate safety, quality and efficacy

2. You will lead internal/external quality audits. Ensure implementation of resulting improvement recommendations or compliance gaps, in accordance with the site Quality Plan process as well as take responsibility for reviewing and authorising company documents (e.g. Artwork, Batch Records, and Specifications etc) on behalf of the QA function.

3. Ensure quality support to business partners through involvement with training, non-conformance investigation and reporting, and overall coaching/mentoring of business partners in quality matters. You will also assist investigations of non-conformances and customer complaints including root cause analysis.

4. As the Qualified Person you will operate as a subject matter expert on all matters QA and ensure that
the operational quality team is aware of any changes to legislation, guidelines etc. as issued by the MHRA, Eudralex etc, and ensure that appropriate quality support is always available as required by production.


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. Relevant degree in a scientific discipline (i.e Chemistry, Quality management, Pharmaceutical Chemistry) as well as the eligibility to operate as a Qualified Person as defined in Article 51 of 2001/83/EC.

2. Proven industry experience in a GMP environment working with commercial products with exposure to multiple dosage forms. Those with experience of steriles products will take priority on application however not essential.

3. Personnel management / leadership is not required, however those with such experience / a passion of doing so, have the ability to do so as this role can be being structured around your prior experience.

Key Words: Qualified Person / GMP / Quality Assurance / Batch Release / Pharmaceutical QA / Sterile Manufacturing / GMP Compliance / Pharmaceutical Batch Release

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.