Quality Control Scientist - Physical Tester

• To contribute to the delivery of a GMP compliant manufacturing facility that optimises the regional benefit from the £30 million funding provided by NHSE.
• Support physical testing activities under the MMC's MS Licence, ensuring the compliance with MHRA and NHS standards.
• Provides technical resource within area of expertise, advice, and support to ensure GMP compliance at the MMC.

• To be responsible for the environmental monitoring and QC equipment management (validation, Planned Preventative Maintenance (PPM), calibration, contracts etc).
• To perform environmental testing (physical and microbiological) of the cleanroom facility consisting of four cleanroom suites and outer areas according to a regular programme and produce reports with findings.
• To perform environmental testing of clean air devices e.g. isolator qualification.
• To produce documentation such as Quality Control (QC) worksheets, Standard Operating Procedures (SOPs) and review data integrity compliance.
• Contribute to core Pharmaceutical Quality Systems (PQS) such as deviations, change control impact assessments, CAPA etc where relevant to the role.
• To understand and use the Building Management System, where appropriate.
• To support the Senior Physical tester during technical discussions, in particular ISO and GMP standards in clean air classification.
• Perform other testing if applicable, for example compressed air lines to support critical GMP processes.
• To perform temperature mapping as per EU GMP for all temperature-controlled areas, including fridges, freezers, cold rooms, stability chambers, incubators and storage areas.
• To support the QC chemistry and microbiology teams with testing workload where appropriate.
• To role model compassionate and inclusive leadership in order to shape the creation of a collective leadership culture within the trust. This means demonstrating a consistent leadership style which (a) engages, enables and empowers others (b) uses coaching to promote ownership of learning and quality improvement and (c) facilitates team working and collaboration within teams / departments and across organisational boundaries.

Essential

• Degree in relevant scientific discipline e.g. engineering, chemistry or equivalent experience
• Eligible to register with a relevant professional body e.g. General Pharmaceutical Council (GPhC), Health and Care Professions Council (HCPC), Royal Society of Chemistry (RSC) or Royal Society of Biology (RSB), or Royal Pharmaceutical Society (RPS), or engineering registration or medical gas registration

Desirable

• Experience of working in cleanroom environments
• Experience of environmental testing in accordance with GMP and relevant ISO standards e.g. ISO14644 and EU GMP Annex 1
• Experience of gas testing as per European Pharmacopoeia and HTM 02 01 and any other relevant medical gas legislation
• Experience in using GMP Pharmaceutical Quality Systems e.g. SOP, worksheets, Reports, Permit to-Works, Deviations, CAPA
• Knowledge of or experience in coaching and mentoring practices and tools
• Knowledge of or experience in Quality improvement tools, techniques and methods