Senior Quality Assurance Specialist

Senior Quality Assurance Specialist
Location Weybridge - Surrey (Hybrid) 3 days on site , 2 from home
Temporary - Approximately 2- 5 months (could potentially be extended) starting ASAP
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:

• Significant experience and understanding of the requirements of GMP and have the ability to apply knowledge in implementation, monitoring and maintenance to ensure the effectiveness of the GMP QMS.
• Develop and author comprehensive risk assessments for quality-related issues identified in licensed and unlicensed medicinal products, ensuring compliance with regulatory standards.
• Review and approve critical GMP documentation, including Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), Standard Operating Procedures (SOPs), and Validation protocols.
• Lead and coordinate the investigation of deviations, quality incidents, and out-of-specification results when they occurred within the company s external network of contractors.
• 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.
• Monitor quality metrics and trends, driving continuous improvement initiatives.
• 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

• BSc or MSc in a life science subject or comparable experience.
• 5 years+ experience within the pharmaceutical industry, in a GMP role.
• Experience in performing external and internal audits.
• Strong communication skills, attention to detail and the ability to work collaboratively with cross functional teams.
• Comprehensive knowledge of regulations and quality standards relating to Solid/liquid pharmaceutical formulations.

BENEFITS

• Join a friendly, supportive team
• Excellent opportunity to join a global pharmaceutical company
• Hybrid position

BIOTECH