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Regulatory Compliance Officer
2 months ago
Proclinical Staffing is seeking a dedicated Quality Assurance Specialist to perform microbiology testing, isolator and clean room testing, and investigations for deviations. This role involves testing finished products and intermediates in accordance with Good Manufacturing Practices (GMP), dossier, and relevant pharmacopoeia requirements.
Key Responsibilities:
- Perform and oversee testing of intermediate and finished products in compliance with 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 Lot Release and Testing (LROT) procedures, 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) measures.
- Facilitate change management by managing change controls and actioning tasks in the Quality Management System.
- Complete and review Chemical, Biological, Radiological, and Nuclear (CBRN) assessments and risk or manual handling assessments.
- Provide training on test procedures to new team members.
- Enter and lock test results in the SAP system.
- Update Standard Operating Procedures (SOPs) and specifications to ensure they are current and relevant.
- Promote safety within laboratory areas by carrying out safety observations and maintaining CBRN 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.
