Quality Assurance Manager (Stability Storage)
Astoriom,
the global quality leader in safeguarding R&D sample assets,
has an exciting opportunity for a highly motivated, independent and enthusiastic individual to join the Stability Storage team at our Rochdale site. This role will be responsible for the maintenance and improvement of Quality systems and processes within the stability storage business, ensuring Group products, services and systems meet the appropriate regulatory and Group standards, specifically those covering GMP and ISO 9001 across sites in the UK, Ireland and the USA. The Astoriom Quality Management System incorporates Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), ISO 9001 and 15189 registration, Care Quality Commission (CQC) Registration and Human Tissue Authority licensing. Key responsibilities of this role will include: Ensuring continual improvement across the company via the review of feedback and inspection from internal and external sources. Maintenance and review of Controlled Documentation within the Quality Management System. Maintenance of key quality management system processes, including
Incident Management, Complaints, CAP, Supplier Approval, Validation protocol and report review and approval. Performing internal audits and study-specific audits for GMP compliance. Reporting findings to appropriate personnel and monitoring progression of actions to ensure prompt completion through the CAPA system. Hosting Client audits or Regulatory inspections and the development of responses to subsequent reports. Maintain up to date knowledge of relevant regulatory requirements. Being a point of contact for the quality management system and providing guidance and support, where applicable. Providing training in applicable quality concepts and providing the appropriate quality inductions to new recruits. Provide staff training in the Quality Management System and the Principles of GMP as appropriate and identifying relevant quality-related training needs. Liaise with client’s/sponsor’s auditors and ensure execution of corrective action and compliance with customers’ specifications comply with safe working practices in accordance with Company safety policies. Contribute to written reports to the Operations Team and the Executive Management Board. Ability to travel to all facilities and assist with quality activities across the group as required. Skills & Experience: BSc (or equivalent) in a science-based subject or relevant experience within a regulated industry (e.g., GMP, ISO 9001 2015). Minimum Three years’ experience working in a GMP compliant setting. Experience working with a quality management system. Strong administrative and IT skills. Able to travel to sites in Ireland and the USA as required. Experience managing a GMP quality system in an analytical laboratory services environment. Experience in leading internal audits. Experience of participation in regulatory and client audits. Familiarity with Q-Pulse or similar Electronic Quality Management System. Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance
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Astoriom,
the global quality leader in safeguarding R&D sample assets,
has an exciting opportunity for a highly motivated, independent and enthusiastic individual to join the Stability Storage team at our Rochdale site. This role will be responsible for the maintenance and improvement of Quality systems and processes within the stability storage business, ensuring Group products, services and systems meet the appropriate regulatory and Group standards, specifically those covering GMP and ISO 9001 across sites in the UK, Ireland and the USA. The Astoriom Quality Management System incorporates Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), ISO 9001 and 15189 registration, Care Quality Commission (CQC) Registration and Human Tissue Authority licensing. Key responsibilities of this role will include: Ensuring continual improvement across the company via the review of feedback and inspection from internal and external sources. Maintenance and review of Controlled Documentation within the Quality Management System. Maintenance of key quality management system processes, including
Incident Management, Complaints, CAP, Supplier Approval, Validation protocol and report review and approval. Performing internal audits and study-specific audits for GMP compliance. Reporting findings to appropriate personnel and monitoring progression of actions to ensure prompt completion through the CAPA system. Hosting Client audits or Regulatory inspections and the development of responses to subsequent reports. Maintain up to date knowledge of relevant regulatory requirements. Being a point of contact for the quality management system and providing guidance and support, where applicable. Providing training in applicable quality concepts and providing the appropriate quality inductions to new recruits. Provide staff training in the Quality Management System and the Principles of GMP as appropriate and identifying relevant quality-related training needs. Liaise with client’s/sponsor’s auditors and ensure execution of corrective action and compliance with customers’ specifications comply with safe working practices in accordance with Company safety policies. Contribute to written reports to the Operations Team and the Executive Management Board. Ability to travel to all facilities and assist with quality activities across the group as required. Skills & Experience: BSc (or equivalent) in a science-based subject or relevant experience within a regulated industry (e.g., GMP, ISO 9001 2015). Minimum Three years’ experience working in a GMP compliant setting. Experience working with a quality management system. Strong administrative and IT skills. Able to travel to sites in Ireland and the USA as required. Experience managing a GMP quality system in an analytical laboratory services environment. Experience in leading internal audits. Experience of participation in regulatory and client audits. Familiarity with Q-Pulse or similar Electronic Quality Management System. Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance
#J-18808-Ljbffr
