Company Description
Our Client is a successful and growing Pharma & Medtech company.
It is proud to be manufacturing in the UK and we are working very closely with its Aseptic facility to identify a new leader of Aseptic Quality.
Role Description
The duties are as you would expect in a dynamic and high output aseptic manufacturing site.
Leading the QA & QC team this is the prime role ensuring all manufacturing activities are conducted in compliance with the Human Medicines Regulations, MHRA expectations, and GMP.
Acting as the RP for Quality Control for the manufacture of unlicensed medicines the post holder will have legal and professional accountability for the quality, and compliance of Specials manufactured under the company's Manufacturer's Specials Licence and the final release of finished products for the aseptic production unit.
The daily operations of the QC & QA team also then involves the development and implementation of quality strategies and plans aligned with the company's goals and objectives.
Qualifications
* Proven expertise in Quality Assurance practices, standards, and methodologies
* Experience conducting audits, risk assessments, and gap analyses
* Strong leadership and team management skills
* Proficiency in developing quality manuals, processes, and procedures
* Excellent communication and interpersonal skills to collaborate with stakeholders
* Knowledge of regulatory compliance and industry certifications relevant to Quality Assurance
* Analytical capabilities for problem-solving and process efficiency improvement
* Bachelor's degree in Quality Management, Business Administration, Engineering, or a related field
* Previous experience in a related role within the industry, while not required, will be advantageous
* Familiarity with quality management software and tools is a plus
Salary is excellent and is complemented with an outstanding benefits package.
This is a full time, permanent, onsite role based in the North of England.
Overseas sponsorship is not available for this position.