Role: Microbiology and Sterility Lab Technician

Site Location: Milton Keynes

Rate: £14-16 per hour via PAYE

Duration: 12-month contract

To perform microbiology testing, isolator and clean room testing as well as doing investigations for deviations, implementation of CAPA's and change controls. This role also involves testing of finished products and intermediates in accordance with GMP, dossier and relevant pharmacopoeia requirements.

Roles and Responsibilities

• To perform and oversee testing of intermediate and finished products in accordance with GMP, dossier and where relevant, as per pharmacopoeia requirements.
• Microbiology testing and Training of personnel (Bioburdens, water testing, plate reading, sterility testing, growth promotion, Lungworm testing and Inactivation's) in accordance with SOP's.
• Release of batches in accordance with LROT, escalating any potential affect to supply.
• Raising of deviations in the Quality Management System.
• Supporting with investigations to identify root-cause and implementation of appropriate CAPA's in the Quality Management System.
• Facilitate change management by being a change owner/manager for full change controls and actioning change control tasks generated in the Quality Management System.
• Completion and review of COSHH assessments and either Risk or Manual handling assessments.
• Provide training of test procedures to new members of the team.
• Entering and locking of test results in SAP.
• Update SOP's, and Specs ensuring they are current and relevant.
• Promote safety within the laboratory areas, by carrying out safety observations, ensuring correct signage and maintaining COSHH documentation to prevent or reduce unnecessary exposure to hazardous substances.
• Completion of safety actions within assessnet and Enablon within agreed timelines.

Skills, Knowledge and Abilities

• Microbiology lab experience
• GMP Compliance
• Experience in Quality Control testing
• Laboratory investigations