Qualified Person (Generics QP) - Pharmaceutical
Posted 7 hours ago by Radar Recruitment
We are supporting our client, a Pharmaceutical business based in London to hire a permanent Qualified Person (QP) to join them at an exciting phase of growth within the business.
About the company:
Our client operate within the generic pharmaceutical industry and have an ever increasing portfolio of products in the market across various dosage forms, servicing the healthcare sector. There is a great deal of scope for the QP coming in to play a very active and leading role within the business moving forward as they continue to push on with their growth plans.
About the role:
The QP will work closely with the leadership team and the wider the QA function to ensure effective functioning of the Quality Management System and contribute to the overall GMP strategy. You will be responsible for reviewing and certifying product batches for human use in compliance with the Manufacturing Licence (MIA) and EU GMP Guidelines and Directives.
Some of the key responsibilities for the Qualified Person (QP) will involve the following:
About the company:
Our client operate within the generic pharmaceutical industry and have an ever increasing portfolio of products in the market across various dosage forms, servicing the healthcare sector. There is a great deal of scope for the QP coming in to play a very active and leading role within the business moving forward as they continue to push on with their growth plans.
About the role:
The QP will work closely with the leadership team and the wider the QA function to ensure effective functioning of the Quality Management System and contribute to the overall GMP strategy. You will be responsible for reviewing and certifying product batches for human use in compliance with the Manufacturing Licence (MIA) and EU GMP Guidelines and Directives.
Some of the key responsibilities for the Qualified Person (QP) will involve the following:
- Performing QP batch release and support with the day-to-day operation of the Quality Management System as well as performing QP batch certification.
- Timely QP certification for release of all products.
- Advise Senior Management if there are any significant GMP compliance risks ensuring the business are meeting cGMP requirements relevant to this industry e.g. Data Integrity, FMD/safety features.
- Take a leading role in the management of/participation in Recalls in conjunction with the MHRA, Third Party Suppliers and Customers.
- Audits of CMO’s & external vendors, where required, and approving Technical Agreements with service providers.
- Hosting regulatory inspections and managing the audit report responses.
- Experienced QP with demonstrable experience of working with Generics.
- Eligible to be added as a QP to an MIA under the permanent provisions of Directive 2001/83/EC for Medicinal Products for Human Use.
- Scientific Degree – ideally in a pharmaceutical discipline.
- Strong understanding and experience working with Oral Solid Dosage (OSD) forms and injectables is highly desirable.
- Member of professional body, with strong evidence of continued professional development.
- Experience of hosting customer & Regulatory audits as well as supporting internal audits.
- Type:
- Permanent
- Contract Length:
- N/A
- Contact Name:
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- Telephone:
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- Job Reference:
- 591751
- Job ID:
- 222370077
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