Quality Assurance Specialist
5 days ago
Job Overview
Hobson Prior is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the quality of products used in clinical trials.
Key Responsibilities
- Product Batch Review and Approval: Conduct thorough reviews of product batches to ensure they meet quality standards.
- Quality Issue Investigation and Resolution: Investigate and resolve any issues related to product quality, ensuring timely and effective resolution.
- Training and Development: Assist the Quality Assurance Manager in training and developing Quality Assurance Officers, ensuring they have the necessary skills and knowledge to perform their duties.
- Audit Preparation and Hosting: Collaborate with the Quality Assurance Manager to prepare for and host audits, ensuring compliance with regulatory requirements.
- Staff Training and Documentation: Ensure all staff complete and document necessary training each year, maintaining accurate records.
- Label and Batch Record Creation: Ensure labels and batch records are created in a timely manner according to the production schedule.
Requirements and Qualifications
- Knowledge of Aseptic or Terminal Sterilisation: Possess knowledge of aseptic or terminal sterilisation, ideally sterilisation by filtration or moist heat.
- Annex 1 Requirements and Controls: Have experience with Annex 1 requirements and controls for sterile manufacturing.
- Contamination Control Strategy: Develop and maintain a contamination control strategy, including Environmental Monitoring Strategies.
About Hobson Prior
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. We are committed to providing our clients with the highest level of service and expertise in the industry.
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