R&D ManagerOxfordshireFull time, permanentSalary negotiableAnnual bonus of 5% of salaryContributory, salary sacrifice, pension scheme up to 5% of salary25 days of holiday (increasing to 28...
Attractive salary & package
Are you an excellent Quality Manager?Do you have experience in CMC?
- Overseeing the Quality Management System for CMC. Review processes and summarise in process maps. Establishing processes to ensure data integrity and communicating the principles of data integrity.
- Assist in managing the core QMS and QA processes including being Process Owner for some agreed core QMS Processes.
- Performing internal system audits for CMC as defined in Internal Audit Schedule. Prepare audit plans, perform and reporting audit findings to the auditee, Head of Functional area and Head of QA.
- Assist 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.
- Maintaining an up to date knowledge and log of applicable legislation and regulatory guidelines. Understand and interpret the regulatory expectations and provide guidance on their implementation.
- Provide in-depth quality reviews of data and documentation, as required.
- Assisting with the smooth running of the regulated CMC facilities.
- 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 injectables.
- 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).
If you have the skills/experience required and are interested in the role please apply online, should you have any questions please call on 0121 728 8455 to discuss.