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