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Quality Assurance Manager
SRG
- Manchester, England, United Kingdom
- Manchester, England, United Kingdom
Über
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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Sprachkenntnisse
- English
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