Quality Assurance Validation, Lead Specialist - PPQ/Process Validation
My client is a small to medium size biotech firm in the Greater Boston Area looking to add a specialist to their firm. This individual would offer a resource in assistance with the PPQ lifecycle and process validation activities. They are a completely virtual looking for personnel to assist in IND-enabling, clinical and commercial projects as they bring a gene therapy product to market.
- Expertise in Tech Transfer activities
- QA Approval of change controls and validation documents e.g. Impact Assessment, Risk Assessment, Protocol, Report, and User Requirements.
- Past experience leading, or working with Process Performance Qualifications (PPQ) and Process Validation
- Knowledge of Process Validation and critical attribute assessments
- TTP Generation
- Process Development experience, preferred
- Represent the Quality Assurance Validation group in project teams.
- Provide Quality Assurance Validation support to CMC and Tech Transfer teams.
- Thorough knowledge and understanding of FDA and foreign requirements and expectations
- Provide support and guidance in the development and execution of CxO validation / qualification documentation.
- Wide range of expertise or working knowledge across validation disciplines including process validation, method validation, and cleaning validation.
- PPQ AND/OR Process Validation Lifecycle experience is required in this position
- Expertise in support of Tech Transfer initiatives.
- Bachelors' and/or Masters' degree in Engineering, Biochemistry or related field required.
- Technical understanding of biopharmaceutical production. Expertise in best practices for aseptic processing and contamination control
This is a unique opportunity within a project based group. The opportunity is an immediate need with the likelihood to move forward with the ideal candidate pretty quickly. If you, or some in your network, are interested in this position please apply or send an updated version of your resume to Ahmed Hassan and team at Real Staffing, Boston.
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