competitve salary and benefits
Opportunity for a qualified person (QP), to join a well-respected pharma company with ambitious growth plans.
The hiring business has invested heavily in its South Wales facility and is currently going through a period of expansion.
As a qualified person (QP), you will work closely with the quality director. Your focus will be the certification of manufacturing process and activities performed under the companies MHRA licence. Specific responsibilities will include: -
- Reviewing batch manufacturing documents to ensure compliance with EU GMP and the product specification file/marketing authorisation.
- Certifying medicinal products for use in and outside of the EU.
- Auditing to ensure that sponsor or MH holder manufacturers are EU GMP compliant.
- Guiding internal and external customers on QP requirements.
- Assisting with regulatory inspections and client audits.
- Supporting the maintenance and development of the quality management system.
- Deputising for the lead qualified person.
To apply for the qualified person (QP) position, you will require
- Eligibility to act as a qualified person (QP) for the certification of marketed products and investigational medicinal products per EU directives 2001/83/EC and 2001/20/EC.
- Experience working as a QP, ideally including sterile medicinal products and biopharmaceutics manufactured aseptically.
- GMP auditing experience, preferably with a lead auditor qualification.
- For the right person, the client will also consider a candidate who is partway through QP qualification.
In return, the qualified person (QP), will receive a generous salary, with an excellent benefits package. There may also be an opportunity to receive relocation support.
To find out more about the qualified person position, please click apply!
By applying you're giving consent for the Sigma Recruitment agency in Cardiff, to contact you regarding this job and other vacancies we're recruiting for.
Job Skills: Qualified Person, QP, Pharma, Pharmacutical, [email protected]