A leading biotechnology company is seeking to recruit a Qualified Person to their office in London. The company is known for their work in developing therapeutics that treat rare genetic diseases, some of which affect as few as 1000 people worldwide. This is an exciting opportunity to join a dynamic global business and support its commercial presence across Europe, along with other regions.
- Ensuring that prior to the certification of any given batch of formulated bulk drug substance, drug product and finished goods, each batch has been manufactured and tested in accordance with the requirements of its Marketing Authorization or Product Specification file and the principles of current Good Manufacturing Practice (cGMP) prior to final release of the batch.
- Quality oversight of contract manufacturers, testing and for leading, monitoring and supporting the quality performance of quality systems according to GMP standards.
- Taking part in Material Review Boards, CMO Quality Reviews, Supply planning and Product Governance Meetings.
- Partnering with departments across the company and with CMO's providing Quality Oversight of CMO's.
Skills and Requirements:
- 8+ years' experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in Quality Assurance, Batch Release and Compliance.
- Maintain knowledge up-to-date with respect to the current Good Manufacturing Practices (cGMP), technologies and quality systems for the products they certify.
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
- 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 Steve Fuller at +44 203 854 2630 or 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.