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
* Perform and oversee testing of intermediate and finished products in accordance with GMP, dossier and relevant pharmacopoeia requirements.
* Conduct microbiology testing and train personnel (Bioburdens, water testing, plate reading, sterility testing, growth promotion, Lungworm testing, and Inactivations) in accordance with SOPs.
* Ensure all activities are performed in compliance with GMP, MSD quality guidelines, and pharmacopoeia.
* Release batches in accordance with LROT, escalating any potential impacts to supply.
* Raise deviations in the Quality Management System.
* Support investigations to identify root causes and implement appropriate CAPAs 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.
* Complete and review COSHH assessments and either Risk or Manual handling assessments.
* Provide training on test procedures to new team members.
* Enter and lock test results in SAP.
* Update SOPs and Specs ensuring they are current and relevant.
* Promote safety within laboratory areas by carrying out safety observations, ensuring correct signage, and maintaining COSHH documentation to prevent or reduce unnecessary exposure to hazardous substances.
* Complete safety actions within assessnet and Enablon within agreed timelines.
* Upload company procedures regarding GMP and comply with UK pharmaceutical regulations.
* Comply with the 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
* Proficient in MS Word and Excel
* Ability to identify deviations and raise events in the Quality Management System.
* Support troubleshooting to help resolve issues.
* Protocol, hypothesis, and report writing
* Ability to troubleshoot and 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 in the first instance
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