Are you an experienced Quality Assurance Leader looking for a challenge with a really exciting CDMO focused on Pharmaceutical Manufacturing?
Job Title: Quality Assurance Manager
Type: Permanent
Salary: Highly attractive
Location: Northwest, England
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.
Typical responsibilities / accountabilities :
* 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 lifecycle, 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 reoccurrences of nonconformance, 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.
Essential Requirements :
* Minimum of 5 years' of recent experience in Quality Assurance within a Pharmaceutical (GMP) facility, preferably Investigational Medicinal Products (IMPs)
* Proven Leadership / Management experience
* Degree or equivalent in a relevant scientific discipline desired
* Experience in working with analytical laboratories and / or GMP production areas.
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