Senior QA Specialist

A private biopharmaceutical company is seeking to recruit a Senior QA Specialist to their office in Stevenage. The organisation focuses on the development and commercialisation of engineered T-cell immunotherapy products with extreme efficacy in the treatment of life-threatening cancers. This is an exciting opportunity to work with a dynamic and innovative company that is revolutionising the medical industry,

Job Responsibilities:

• Performing documentation management, overseeing GMP policies, procedures, Production and Quality Control (QC) records/pro-formas, and Pharmaceutical Quality System (PQS) templates.
• Recording reviews on Environmental Monitoring (EM), Production, and QC.
• Planning preventative maintenance and equipment calibration management.
• Reviewing and releasing materials for use in Production, QC, Starting material, and critical raw material sample management and retention.
• Conducting self-assessments in accordance with a defined schedule.

• Managing deviations within a PQS, including coordinating change controls, quality exceptions, microbiological out-of-trend and out-of-specification results, and other environmental excursions.
• Validating equipment and facilities and performing revalidation on protocols and maintenance.
• Performing assessment and qualification (or disqualification) of raw material suppliers, including audits.
• Auditing GMP contractors whilst conducting outsourced activities.
• Performing Product Quality Review and Risk assessments with respect to product quality and health and safety.
• INDLP.

Skills and Requirements:

• Bachelor's degree.
• Demonstrable experience in a similar or relevant capacity.
• 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 Joshua Godden at + 44 2038540101 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.

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