Status:
Immediately available for Contract QP assignments (2-3 days per week)
Location:
South East (UK)
Desired location:
South East (UK)
Basic salary:
Please enquire for day/hourly rate
Exp. years:
25
Specialisms:
Eligible IMP and Commercial Qualified Person- Sterile Manufacturing
Job Type:
Contract
Availability:
Immediately available
Overview:
A Quality Assurance Professional with 25 years broad experience and a proven track record in pharmaceutical GMP gained in quality-orientated roles, in both commercial manufacture and drug development.
- Eligible as a Qualified Person for the release of Investigational Medical Products (IMPs) under the clinical trials directive 2001/20 EC and commercial products under directive 2001/83/EC.
- Supporting product development activities through all phases of development
- In-depth manufacturing knowledge of solid dosage forms, metered dose inhalers, oral liquids and sterile manufacturing processes including radiopharmaceuticals.
- Perform GDP and GMP auditing of API and drug product manufacturing sites.
- Act as responsible person and responsible person for import.
- Provide QP oversight for the import of IMP from countries on the MHRA approved list.
- Proven quality management system support including complaints management, technical agreements, SOP approval, change control, deviation and Vendor & CAPA management.
- GMP training, staff mentoring and QP viva preparations.
