*Management of the Quality Management System for CMC. Review processes and summaries in process maps. Establishing processes to ensure data integrity and communicating the principles of data integrity.
*Help in oversight of the core QMS and QA processes including being Process Owner for some agreed core QMS Processes.
*Carrying out internal system audits for CMC as laid out in Internal Audit Schedule. Prepare audit plans, perform and reporting audit findings to the auditee, Head of Functional area and Head of QA.
*Help in other internal audits, as required.
*Leading audits of third party providers for CMC (excluding those requiring a QP) as per Supplier Audit Schedule and assist/support other Supplier Audits.
*Keeping to date knowledge and log of applicable legislation and regulatory guidelines. Understand and interpret the regulatory expectations/provide guidance on their execution.
*Provide in-depth quality reviews of data and documentation, as is neccessary.
*Assisting with the running of the regulated CMC facilities. Providing guidance on the following:
Non-conformances and Quality Events
Supplier Assessment and Management
Root Cause Analysis and CAPA
Complaints and Product Recall
*Provide training/mentoring on any aspect of Quality as required.
*Contribution to the scientific, intellectual property, and business development aspects of the company's activities in order to grow its value.
*Excellent understand of quality management systems and "good practices" (GxP), to ensure compliance with regulatory requirements
*Excellent knowledge of GMP (GCP and GLP an advantage)
*Previous experience of working in Clinical Research or the Pharmaceutical Industry
*Knowledge of the Industry manufacturing process and drug development
*Knowledge of the manufacture of sterile injectable T cell antigen receptor-based therapeutics produced in bacterial cell culture.
*Work collaboratively with existing teams
*Able to foster support and influence all stakeholders throughout the company
*Extensive experience within Quality Assurance in a similar industry
*Excellent proven auditing, written and oral communication skills.
*Worked with Microsoft Office at an intermediate level (i.e. Word, Excel, PowerPoint Outlook)
*Previous experience of managing quality systems in the pharmaceutical or Biotech industry
*Knowledge of GCP and GLP
*Knowledge of the Industry/Clinical trial process and drug development
If the position outlined may be of interest, please do get in touch with Ross Wilson either at firstname.lastname@example.org or on +44(0)1727 817621
You must be eligible to work in the UK. Learn more
- Agency: Key People
- Reference: 24144
- Posted: 29th March 2019
- Expires: 26th April 2019