Senior Quality Assurance Specialist
Location: Weybridge - Surrey (Hybrid) 3 days on site, 2 from home
Type: Temporary - Approximately 2-5 months (could potentially be extended) starting ASAP
Industry: Bio-Pharmaceutical
We are seeking a Senior Quality Assurance Specialist to join our global pharmaceutical client based in Weybridge, Surrey.
KEY DUTIES
Your duties as a Senior Quality Assurance Specialist will include:
1. Significant experience and understanding of the requirements of GMP and the ability to apply knowledge in implementation, monitoring, and maintenance to ensure the effectiveness of the GMP QMS.
2. Develop and author comprehensive risk assessments for quality-related issues identified in licensed and unlicensed medicinal products, ensuring compliance with regulatory standards.
3. Review and approve critical GMP documentation, including Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), Standard Operating Procedures (SOPs), and Validation protocols.
4. Lead and coordinate the investigation of deviations, quality incidents, and out-of-specification results when they occur within the company's external network of contractors.
5. Develop effective Corrective and Preventive Actions (CAPAs) plans for application externally and within the company. Monitor progress and close out of these CAPA within the QMS.
6. Monitor quality metrics and trends, driving continuous improvement initiatives.
7. This role involves overseeing the quality of all products manufactured or sourced by the company to ensure adherence to GMP and documented procedures.
WHAT YOU WILL NEED
1. BSc or MSc in a life science subject or comparable experience.
2. 5 years+ experience within the pharmaceutical industry, in a GMP role.
3. Experience in performing external and internal audits.
4. Strong communication skills, attention to detail, and the ability to work collaboratively with cross-functional teams.
5. Comprehensive knowledge of regulations and quality standards relating to solid/liquid pharmaceutical formulations.
BENEFITS
1. Join a friendly, supportive team
2. Excellent opportunity to join a global pharmaceutical company
3. Hybrid position
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