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Quality Assurance Specialist
2 months ago
Job Summary:
Proclinical Staffing is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality and integrity of our products and processes.
Key Responsibilities:
- Perform and oversee testing of intermediate and finished products in compliance with Good Manufacturing Practices (GMP) and pharmacopoeia requirements.
- Conduct microbiology testing and train personnel on procedures such as bioburdens, water testing, plate reading, sterility testing, growth promotion, and inactivations.
- Ensure all activities comply with GMP, quality guidelines, and pharmacopeia standards.
- Release batches in accordance with LROT, escalating any potential supply issues.
- Raise deviations in the Quality Management System.
- Support investigations to identify root causes and implement appropriate Corrective Action Preventive Action (CAPA) plans.
- Facilitate change management by managing change controls and actioning tasks in the Quality Management System.
- Complete and review COSHH assessments and risk or manual handling assessments.
- Provide training on test procedures to new team members.
- Enter and lock test results in SAP.
- Update SOPs and specifications to ensure they are current and relevant.
- Promote safety within laboratory areas by carrying out safety observations and maintaining COSHH documentation.
- Complete safety actions within agreed timelines.
- Comply with company procedures regarding GMP and UK pharmaceutical regulations.
- Adhere to company health and safety practices and procedures.
Requirements:
- A degree in Science is a necessity.
- Experience in a microbiology lab and GMP compliance.
- Proficiency in Quality Control testing and laboratory investigations.
- Familiarity with MS Word and Excel.
- Ability to identify deviations and raise events in the Quality Management System.
- Strong troubleshooting skills to resolve issues.
- Proficient in protocol, hypothesis, and report writing.
- Effective communication skills at all levels and across functions.
- Good time management in a high-throughput laboratory.
- Flexible approach to changing priorities and good attention to detail.
