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Are you an experienced Quality Assurance Leader looking for a challenge with a really exciting CDMO focused on Pharmaceutical Manufacturing? SRG is currently working exclusively with a highly successful, award winning, contract development and manufacturing organisation focused on providing expert intelligence and support to their partners, driven by their capabilities. As a result of expansion, we are looking for a Quality Assurance Manager to join their quality team.
Job Responsibility:
Ensure full compliance with UK/EU GMP Regulatory Standards and company procedures
Lead and manage the Quality Assurance Team at an IMP manufacturing site, focused on Phase I and Phase II clinical trial materials
Maintain QA systems and processes, reviewing and supporting ongoing improvement activities
Ensure effective management of documents through life-cycle, ensuring compliance with regulations and industry best practices. This includes - creating, reviewing, and approving key documentation such as specifications, SOPs, protocols, and methods associated with all products and procedures
Support batch documentation review and provide quality oversight for the certification and release of IMPs by the QP
Investigating and approval of deviations, complaints and OOS to prevent future re-occurrences of non-conformance, providing support on SMART CAPA plans
Supplier Management: Managing supplier approval and ongoing performance
Evaluating site compliance and implementing improvements through the internal audit process, as an Internal Auditor and Report approver
Supporting Client projects as a Quality Assurance representative and Customer liaison
Support generation and cascade of quality training packages, including but not limited to GMP induction and annual refresher
Assist with management of Regulatory inspections: inspection readiness, inspection and response
Requirements:
Proven Leadership/ Management experience in Quality Assurance within a Pharmaceutical (GMP) facility
Degree or equivalent in a relevant scientific discipline
Experience in working with analytical laboratories and/ or GMP production areas
Nice to have:
Experience with Investigational Medicinal Products (IMPs) would be advantageous