Oxfordshire, United Kingdom
£30,000 - £35,000 + Benefits
about 2 years ago
Quality Assurance Scientist
Summary of Job Description:
The QA Scientist is responsible for the maintenance of the Quality Assurance activities and Quality Management System (QMS)..
Assisting Senior Management and the Senior QA Scientist to evaluate and assure appropriate
Quality Systems are in place at approved vendors and suppliers providing Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) services.
Ensuring all relevant quality and regulatory requirements are met for quality control testing and contract manufacturing. Ensures site compliance with Quality Systems Regulations
issued by MHRA, FDA and other applicable regulatory bodies where our products are being developed.
Assist the Senior QA Scientist to develop and maintain the Quality Management System in accordance with applicable standards established by MHRA, FDA and other applicable regulatory bodies.
Interface with internal teams in Product Development, QC, Clinical, Research and, as appropriate, with external vendors such as Contract Manufacturing Organizations, and other service providers to ensure compliance with the requirements and quality standards.
Participates in coordinating daily activities within the assigned functional area.
Provide support to Product Development for regulatory activities, to facilitate CTA and
IND approvals of the Company’s pipeline of exosome therapeutics.
Ensure QA standards are maintained in control of documentation, staff training, facilities, equipment, and archiving.
Assist in the development, management and review of the site validation plans.
Draft, review and provide oversight to content of documents which may include but are not limited batch records, Assay sheets, logbooks, material specifications, and
QA review and approve all 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, facility & equipment records.
The preparation of reports, certificates of analysis and regulatory documents in support of submissions to regulatory authorities.
Assist in the management programme of internal and external audits.
Participate in internal audits as required.
Assist in QA and OOS investigations.
Provide QA support for the development of new processes or testing methods developed.
Generate metrics for the monthly Quality Management System meeting.
Assist/Lead in staff training in QA procedures.
Monitor GCLP testing of clinical samples.
Ensure regulatory compliance in all countries that operate or conduct clinical trials.
Degree (BSc) in an appropriate science subject
Experience and skill requirements:
1+ years relevant work experience within the pharmaceutical/biotech industry in a QA function. The holder is likely to have other relevant experience within the industry, such as QC, GLP, GCP or GMP production.
Familiarity with FDA/MHRA regulations, ICH guidelines and current industry practices.
Ability to define problems and prioritise issues.
Ability to plan and organise workload including evaluation and prioritisation of current tasks and forward planning for future events.
Demonstrate ability to make decisions, take responsibility and exercise judgement.
Use initiative to resolve problems, anticipating and pre-empting situations and handling pressure.
Show enthusiasm, energy and commitment to role.
Strong team player to work towards team goals and effectiveness.
Demonstrated ability to work in a cross-functional team environment.
Good verbal and written communication skills.
Have strong computer software skills.