Mantell Associates is partnered with a rapidly growing Pharmaceutical organisation who are seeking a Senior Quality Assurance Specialist to join their talented team.
Senior Quality Assurance Specialist - Responsibilities
* Oversee the New Product Introduction (NPI) process responsible for onboarding new customers and products to ensure successful clinical and commercial drug product manufacturing
* Lead the Product Quality Team responsible for disposition of batches, tracking batch release, and partnering with other departments to close out all required deliverables to support product disposition
* Develop and oversee the Quality on the Floor Program responsible for visual inspection and packaging operations
* Provide strategic guidance to resolve complex investigations and product quality issues
* Reviews and approves Commissioning and Validation protocols and final reports
* Reviews and approves QC stability study summaries, protocols, and final reports
Senior Quality Assurance Specialist - Requirements:
* Scientific degree and strong experience in Quality Assurance leadership in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility
* GMP compliance knowledge
* Able to efficiently prioritise workload across the team
* Team player with exceptional communication skills, a concern for excellence, ability to develop and mentor a team, and a high ability to collaborate with various levels of the organisation
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.