Job Details
A fantastic opportunity has become available for a Quality Technician to work with one of my Pharmaceutical clients.
• To perform testing of intermediate and finished products in accordance with GMP, dossier and where relevant, as per pharmacopoeia requirements.
• Microbiology Testing (Bioburdens, plate reading, sterility testing, growth promotion and Inactivation’s) in accordance with SOP’s.
• Liaise with other professionals regarding the development, manufacturing and testing of pharmaceutical products.
• Ensure all activities are performed in compliance with GMP, quality guidelines and pharmacopeia.
• Actively contributes to Laboratory Improvement activities.
• Perform and trend environmental monitoring and water testing.
• Report and investigate OOS result, lab investigations to identify root causes.
• Raise CAPA actions and ensure results are reliable, batches are released on time and lab errors are at the absolute minimum.
• Update SOP's, and Specs ensuring they are current and relevant to updated in order to minimise time taken to release batches, eradicating unnecessary delays.
• 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.
• SAP – ensure timely completion of results in SAP and up to date specifications for microbiology lab tests. Other responsibility
• To upload company procedures in regard to GMP and comply with UK pharmaceutical regulations at all times.
• To comply with company’s health and safety practices and procedures The above list of duties is not exhaustive and is subject to change. The post holder may be required to undertake other duties within the scope and grading of the post.
Experience Required
* Expertise in Immunology techniques such as ELISA’s, haemagglutination tests, antigen mass assay is essential.
* Good understanding and working knowledge of GMP Quality Systems
* Technical expertise in ELISA’s and other immunology techniques, including microbiology techniques.
* Proficient in use of Microsoft Office especially Excel and Word.
* Good Protocol and Report writing skills.
* Ability to troubleshoot to resolve issues
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