Senior QA Specialist

Hobson Prior is seeking a Senior QA Specialist. The focus of this role is to lead the GMP quality assurance activities promoting and integrating quality into every aspect of our business, providing quality assurance expertise and input on the quality management system (QMS) compliance for Serb Pharmaceuticals at Weybridge, Surrey. This role will perform a variety of tasks in support of GMP Compliance of the site quality assurance function. Duties will include handling site quality issues including compliance, validation, internal audits, project management & execution, and quality documentation, under the leadership of the Quality Assurance Manager.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• 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.
• Perform and lead GMP audits of contractors as assigned by the QMS and in support of the wider company as required.
• Review and coordinate Product Quality Reviews generation as required.
• Perform internal audits in accordance with company's QMS requirements.
• Support the ongoing development of the Quality Assurance team including managing the day-to-day operational activities in the absence of the QA Manager.
• Ensure that quality related tasks are prioritised appropriately.
• Ensure that the QA group responds to the requests of other teams in a timely and supportive manner.
• Collaborate with cross-functional teams to implement quality enhancements.
• Ensure effective communication with all stakeholders.
• Ensuring all our suppliers meet company's high standards for quality and compliance.

Key Skills and Requirements:

• BSc or MSc in a life science subject or comparable experience.
• Proven working 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.

For more information, please contact Frankie Cunningham.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click 'Apply' and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please select 'Contact me' at the top of this page.