Description
An innovative Pharmaceutical manufacturer based in the South-East is currently looking for an experienced Qualified Person (QP) to join the team in line with a continued period of growth.The responsibilities of the Qualified Person (QP) are as follows:
* Act as one of the designated registered QP’s on site named on the company license.
* Responsible for Batch release of Oral Solid Dose Presentations (OSD)/IMP products.
* Support clients in matters relating to regulatory submissions and remain up to date on the changes in regulatory matters and the effects of these both internally and for external regulatory authorities.
* Develop and implement programs to assure compliance with regulatory (MHRA and others) requirements, as well as the standards for quality and performance set by internal and external stakeholders.
* Create, maintain and champion a culture of exceptional quality, regulatory compliance.
To fulfil these requirements for the Qualified Person (QP), you must have the following skills/experience:
* Strong Background working within a highly regulated Pharmaceutical manufacturing environment with specific experience of batch release on Oral Solid Dose (OSD) presentations/IMP’s.
* Thorough knowledge of cGMP’s and pharmaceutical manufacturing requirements.
* Experience in leading/taking part in MHRA/FDA inspections would be beneficial.
* Eligible to act as a QP under permanent provisions/Educated to degree level/equivalent experience.
* Excellent communication and presentation skills.
The successful Qualified Person (QP) will have the chance to work in a very reputable company within the Biopharmaceutical industry, during a very exciting period and receive competitive rates of pay.