Status:
Available for QA Consultancy roles immediately (UK Wide)
Location:
South East (UK)
Desired location:
United Kingdom
Basic salary:
Please enquire for hourly rate
Exp. years:
17
Specialisms:
QA, QC, QMS, Remediation, Microbiology, Sterile Manufacturing, MHRA, FDA, ANVISA
Job Type:
Contract
Availability:
Immediately available
Overview:
- A dynamic and proactive consultant with over 17 years of expertise in Pharmaceutical Microbiology, particularly in the manufacture of sterile products.
- Working expertise in sterile pharmaceuticals and vaccine manufacturing, as well as developing and improving systems, equipment, and processes in a GMP-compliant and lean manufacturing environment.
- Involvement as a Subject Matter Expert in external MHRA, FDA, ANVISA, and Health Canada audits, as well as other client and internal corporate audits.
- Performance of risk assessments to identify key risk areas and development of CAPA plans in order to reduce risk of contamination, improve contamination detection and improve regulatory compliance.
- Matrix management and coordination of departmental resource to resolve QMS backlog and drive MHRA Remediation and continuous improvement initiatives.
- FDA Inspection Remediation CAPA support and staff coaching
- Leading microbiology function in provision of testing service for in-process and non-sterile final product raw materials, cleanroom environmental monitoring, water systems, development products as well as cleaning validation.
For the candidates full CV, please send a request or contact AssureBio on 0208 064 0012.
