Quality Assurance Specalist

A clinical-stage biopharmaceutical company is seeking to recruit a Quality Assurance Specialist to their office in the UK. The organisation develops next generation, programmed T cell therapies for the treatment of cancer and pride themselves on their broad suite of proprietary and modular T cell programming technologies. This position presents a fantastic opportunity for a bright, enthusiastic scientist to join an innovative company that is committed to delivering high quality products for use in clinical trial programmes.

Job Responsibilities:

• Documentation management, including GMP policies, procedures, Production and Quality Control (QC) records/pro-formas, and Pharmaceutical Quality System (PQS) templates.
• Record review (Environmental Monitoring (EM), Production and QC.
• Planned preventative maintenance and equipment calibration management.
• Materials review and release for use in Production and QC and Starting material and critical raw material sample management and retention.
• Conducting self-assessments in accordance with a defined schedule.
• Deviation management within a PQS including coordinating change controls, quality exceptions, microbiological out-of-trend and out-of-specification results and other environmental excursions.
• Equipment and facilities validation and revalidation protocols and maintenance.
• Assessment and qualification (or disqualification) of raw material suppliers, including audits.
• Audits of GMP contractors conducting outsourced activities.
• Product Quality Review.
• and Risk assessments with respect to product quality and health and safety.
• INDLP.

Skills and Requirements:

• 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.

To Apply:

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 Marjolene D'Almeida-Ayeni at +44 203 854 2626 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.

Proclinical Staffing is an equal opportunity employer.

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