Job Description

Role: Quality technician

Location: Milton Keynes

Duration: 12 months initially

Rate: 18.25 PAYE

Inside IR35

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.

Key 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.
• Ensure all activities are performed in compliance with GMP, MSD quality guidelines and pharmacopeia.
• 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.
• Other responsibility
• To upload company procedures regarding GMP and always comply with UK pharmaceutical regulations.
• To comply with company's health and safety practices and procedures

Qualifications / Requirements

Knowledge

• Microbiology lab experience
• GMP Compliance

Experience

• Experience in Quality Control testing
• Laboratory investigations
• (DESIRABLE ONLY) Previous roles include interaction with Production/Manufacturing departments.

Skills and Ability

• MS Word and Excel
• Ability to identify deviations and raise events in the Quality Management System.
• Ability to support with troubleshooting to help resolve issues.
• Protocol, hypothesis, and Report writing
• Ability to troubleshoot resolve issues

Personal Attributes

• Able to communicate at all levels and across all functions
• Ability to communicate concise technical information with clarity
• Good Time Management in a high flow through laboratory
• Flexible approach to changing priorities
• Attention to detail

To apply, please submit your CV's in the first instance