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QA Manager
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Proclinical is seeking a QA Manager to be based in Stevenage on a permanent basis.
Job Responsibilties:
- Lead QA support for GMP manufacturing activities in the company's GMP module at the Catapult Cell and Gene Therapy Manufacturing Centre in Stevenage
- Provide QA oversight of work executed at third party GMP manufacturing and testing service providers
- Provide QA input into Change Controls, Deviations, OOS reports and CAPAs
- Lead Quality investigations and perform risk assessments
- Review of CMC sections of regulatory filings
- Conduct external audits of GMP service providers
- Review of executed batch manufacturing, QC and stability records
- Review and approval of qualification, validation and tech transfer activities
- Assist with coordination of vendor assurance programme
- Perform preliminary batch record review prior to batch certification by QP
- Quality representative for specific projects
- Working with Manufacturing and Quality Control to determine appropriate specifications
- Conduct internal audits of manufacturing and testing facilities and processes
- Support Competent Authority inspections (MHRA and US FDA)
- Assist with any recalls or customer complaints
Skills and Requirements:
- Educated to degree level or equivalent in a biological or physical science
- Experience in Quality Assurance in the pharmaceutical/biotech industry, minimum 6 years GMP experience with minimum 2 years in biologics.
- Demonstrates a thorough understanding of biologics or ATMPs manufacturing for clinical development.
- Prior experience auditing contract manufacturers and suppliers
- Excellent planning and organisational skills
- Ability to work in a small team in a dynamic environment
- Significant experience and/ or familiarisation with Microsoft Office applications (specifically Word)
- Ability to travel to work partners in Europe and US as the role requires
- Excellent interpersonal skills
- Excellent verbal and written communication and computer literacy skills
- Effective time management
- Strong analytical and problem-solving skills
- Proficient with Microsoft Excel and Powerpoint
- GCP/ GCLP experience
- Qualified Person (QP) status would be an advantage but not essential
- Experience implementing electronic document management systems
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Tom Green on +44 203 814 1317 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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