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- Act as Quality Validation Subject Matter Expert (SME) for whole manufacturing site
- Create & manage documents associated with CAPA, Change Controls, and continuous improvement process
- Ensuring GMP Compliance across entire product portfolio for Raleigh manufacturing site
- Creating & implementing key Validation protocols that impact the product
- Regular reviews of Validation & Tech Transfer policies to strengthen company practices
- Minimum Bachelors degree in Life Sciences or Engineering disciplines
- Deep experience in working independently in a Quality Assurance cGMP environment in the Pharmaceutical or Biotech space
- Experienced in Validation / Qualification of products and processes in a Drug Product and Drug Substance environment
- Hands-on experience in Tech Transfer of Drug Product
Quality Validation Lead - Raleigh, United States - SciPro
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Description
Quality Validation Manager – On-Site
This is an opportunity to work on a brand-new Manufacturing site for one of the most innovative and impactful Pharmaceutical manufacturers in the state of North Carolina. With a vast pipeline that is ever growing, we are looking for an experienced and independent expert in Quality & Validation tasks to join the team on a permanent basis as a Quality Validation Manager.
Responsibilities
Requirements
If this is a role that interests you then please click respond through the LinkedIn apply function or send your resume over to