This is an 11-month contract. Fully onsite.
This role requires the delivery of a robust Quality Management System to support a flexible, collaborative, multi-skilled teamwork environment. The team working style is one of collaboration, coaching and facilitation to ensure the success of the site. The Associate Specialist is accountable for the Quality Systems within the site.
• Provides to the site knowledge and experience in Quality Systems and/or Operational Quality, including the following i.e. / Investigations/ Change Management
• Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement and execute tasks.
• Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
• Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
• Supports Corporate Quality to ensure actions related to Quality Systems and/or Operational Quality at the site are executed.
• Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
• Ensure supply of high-quality product through the implementation and oversight of the Quality Management System for the site.
• Ensure the highest Quality, Compliance and Safety standards.
• The Associate Specialist/ Specialist will participate and comply with the Company Quality Management System (QMS) requirements, including ownership.
• The Associate Specialist/ Specialist is accountable for the smooth execution of all appropriate documentation associated within the IPT/QA. He/ She will contribute to the High-Performance culture within the IPT/QA by providing a flexible, accurate service to enable the IPT/QA to achieve four key priorities.
• Is an active member of the cross functional IPT/QA Team, providing support, guidance and expertise to ensure the success of the IPT/QA.
• Will participate and comply with the Quality Management System (QMS) requirements, including ownership.
• Provides to the site knowledge and experience in Quality Documentation Systems. ·
• Responsible for the Site Documentation System including Issuance, reconciliation, storage, archiving and retrieval of cGMP documentation to support the manufacture & testing of our products.
• Complete documentation audits.
• Coaches and guides colleagues within the site.
• Responds to non-standard requests from customer needs.
• Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
• Ensures supply of high-quality products through the implementation and oversight of the Quality Documentation System for the site.
• Champion the highest Quality and Compliance standards for the site.
• Degree or 3rd level qualification (Science, Quality).
• 3 years’ experience in the Pharmaceutical industry.
Purpose The Quality Systems Specialist is responsible for maintaining and continuous improvement of the Quality Management System throughout their knowledge...
Apply For This JobThis is a 12 month contract. Purpose The Medical Device QA Specialist is to provide QMS support for combination products...
Apply For This JobThis is an 11-month initial contract. Purpose Responsible for ensuring that the process for the manufacture of drug products at...
Apply For This JobResponsibilities Provide Quality support to IPT production teams to ensure cGMP standards are maintained. Understanding of sterile manufacturing operations is...
Apply For This JobThis is a 12-month initial contact. Purpose The Senior Quality Audit Specialist will be responsible for supporting the Alexion audit...
Apply For This JobPurpose Associate Quality Specialist supports day to day QA activities in the facility. Responsibilities Participate as functional expert in the...
Apply For This JobTo apply for this job email your details to rachael.kennedy@theaphexgroup.com.
To apply for this job email your details to rachael.kennedy@theaphexgroup.com.