QA Senior Scientist
A leading biotechnology company is seeking a QA Senior Scientist to join their office in Oxford. The organisation focuses on harnessing and engineering the natural delivery capabilities of extracellular vesicles to develop an entirely new class of therapeutics. By creating novel exosome-based therapeutics, this company is able to treat patients with severe diseases that have limited response options. This is an exciting opportunity to work with a dynamic company that uses revolutionary technology.
The Senior QA Scientist is responsible for the maintenance of the Quality Assurance activities and Quality Management System (QMS). They will assist Senior Management in evaluating and ensuring that appropriate Quality Systems are in place at approved vendors and suppliers whilst providing Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) services. They will also ensure all relevant quality and regulatory requirements are met for quality control testing and contract manufacturing, along with ensuring site compliance with Quality Systems Regulations issues by MHRA, FDA, and other applicable regulatory bodies where the company's products are being developed.
- Ensuring that the implementation and maintenance of Quality Management Systems (QMS) is in accordance with applicable standards established by MHRA, FDA, and other applicable regulatory bodies.
- Interfacing with internal teams in Product Development, QC, Clinical, etc., along with external vendors such as Contract Manufacturing Organizations and other service providers to ensure compliance with company requirements and quality standards.
- Providing support to Product Development for regulatory activities to facilitate CTA and IND approvals of the Company's pipeline of exosome therapeutics.
- Ensuring QA standards are maintained in control of documentation, staff training, facilities and equipment, and archiving.
- Reviewing batch manufacturing and testing records and all associated data in preparation for QP release, both primary packaged material, and secondary packaged material for clinical trial supplies.
- Project managing progress of Validation plans.
- Monitoring GCLP testing of clinical samples.
- Overseeing GCP standards through the use of appropriate consultants.
- Managing programme of internal and external audits.
- Providing leadership of QA investigations.
- Ensuring regulatory compliance in all countries in which the company operates or conducts clinical trials.
- QA reviewing and approving all company technical documentation from research, development and clinical function. This will include, but is not limited to, SOPs, reports & protocols, laboratory notebooks, in-house batch records, and facility & equipment records.
- QA reviewing and approving Certificates of Analysis.
- Providing QA support for the development of new processes or testing methods developed by the company.
- Preparing reports, certificates of analysis, and regulatory documents in support of submissions to regulatory authorities.
- Leading internal audits.
- Assisting (lead where necessary) external audits of contractors.
- Generating metrics for the monthly Quality Management System meeting.
- Staff training in QA procedures.
- Interfacing with company QP and other QA consultants
Skills and Requirements:
- Degree (BSc) in an appropriate science subject.
- 2 to 5 years relevant work experience within the pharmaceutical/biotech industry in a QA function.
- Any other relevant experience within the industry, such as QC testing or GMP production.
- Demonstrable project management skills.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Leoca Powell at +44 203 854 2624or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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