Qualified Person (QP)

United Kingdom  ‐ Onsite
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Keywords

Description

A leading pharmaceutical organisation is in need of a Qualified Person (QP) with experience of batch release on Oral Solid Dose/IMP products.

Role:
• Named on the company’s Manufacturing license under EU/Mhra regulations.
• Batch release of Oral Solid Dose Presentations (OSD)/IMP products.
• Support clients in matters relating to regulatory submissions.
• 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.

Role requirements:
• Bachelor's degree in science or life science.
• Registered and practising cGMP Qualified Person under permanent provisions.
• Strong Background working within a highly regulated Pharmaceutical manufacturing environment with specific experience of batch release on Oral Solid Dose (OSD) presentations.
• Experience of working within a MHRA/FDA approved environment.
• Experienced in IMP’s, clinical trial services as well as commercial batch release.
• Thorough knowledge of cGMP’s and pharmaceutical manufacturing requirements.
• Experience in leading/taking part in MHRA/FDA inspections would be beneficial.
• Competent in basic computer software packages e.g. Microsoft Office.
• Hands-on approach with a ‘can-do’ attitude.
• Must be a self-starter who is motivated and able to work under own initiative.
Start date
n.a
From
Quanta Consultancy Services
Published at
02.10.2014
Contact person:
Lee Mitchell
Project ID:
784665
Contract type
Freelance
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