Quality Assurance Manager

Quality Assurance Manager

Birmingham (Office Based)

Up to £65,000 DOE

Urgently needed

Our client is a leading company in pharmaceutical industry, committed to delivering the highest quality products/services to its customers. The company is seeking a dedicated and experienced Quality Assurance Manager to join its team in Birmingham. The ideal candidate will have significant experience working in a Good Distribution Practice (GDP) environment and a strong background in ISO 9001 and ideally ISO 13485 standards.

Key Responsibilities:

• Developing, implementing, and maintaining robust quality assurance policies and procedures.


• Planning and conducting regular internal audits to ensure compliance with company standards and regulatory requirements.


• Overseeing product testing and inspection processes to guarantee product quality and consistency.


• Maintaining meticulous documentation and records of QA activities, including test results, inspection reports, and audits.


• Analysing quality data to identify trends, issues, and areas for improvement, and implementing effective solutions.


• Providing training and support to staff on quality assurance standards and practices.


• Evaluating and managing suppliers and vendors to ensure they meet quality standards.


• Ensuring compliance with ISO 9001 and ISO 13485 (ideally) standards and other relevant regulatory requirements.


• Investigating and resolving quality-related issues and complaints, implementing corrective and preventive actions (CAPA).


• Collaborating with other departments, such as production, engineering, and R&D, to integrate quality throughout the product lifecycle.


• Identifying potential quality risks and developing strategies to mitigate them, including conducting risk assessments and developing contingency plans.

Requirements:

• Proven experience in a quality assurance role.


• Strong background in Good Distribution Practice (GDP) environments.


• Excellent knowledge of ISO 9001 and ideally ISO 13485 standards.


• Exceptional analytical and problem-solving skills.


• Detail-oriented with excellent organizational and record-keeping abilities.


• Strong communication and interpersonal skills, with the ability to train and support staff effectively.


• Experience in supplier and vendor management.

Desirable:

• Responsible Person experience.

If you feel you have the necessary skillset, please apply for immediate consideration.