Role: Quality Technician
Location: Milton Keynes
Duration: 12 months initially
Rate: £18.25 PAYE
Inside IR35
Key Responsibilities:
1. Perform and oversee testing of intermediate and finished products in accordance with GMP, dossier, and relevant pharmacopoeia requirements.
2. Conduct microbiology testing and train personnel in various testing methods (Bioburdens, water testing, plate reading, sterility testing, growth promotion, Lungworm testing, and Inactivation's) in accordance with SOPs.
3. Ensure compliance with GMP, MSD quality guidelines, and pharmacopoeia.
4. Release batches in accordance with LROT, escalating any potential impact to supply.
5. Raise deviations in the Quality Management System.
6. Support investigations to identify root causes and implement appropriate CAPAs in the Quality Management System.
7. Facilitate change management as a change owner/manager for full change controls and action change control tasks generated in the Quality Management System.
8. Complete and review COSHH assessments and either Risk or Manual handling assessments.
9. Provide training on test procedures to new team members.
10. Enter and lock test results in SAP.
11. Update SOPs and Specs to ensure they are current and relevant.
12. Promote safety within laboratory areas by carrying out safety observations, ensuring correct signage, and maintaining COSHH documentation.
13. Complete safety actions within assessnet and Enablon within agreed timelines.
14. Upload company procedures regarding GMP and comply with UK pharmaceutical regulations.
15. Comply with the company's health and safety practices and procedures.
Qualifications / Requirements:
Knowledge:
* Microbiology lab experience
* GMP Compliance Experience
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 proficiency
* Ability to identify deviations and raise events in the Quality Management System.
* Ability to support troubleshooting to help resolve issues.
* Protocol, hypothesis, and report writing skills.
* 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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