Quality Assurance Manager - Responsible Person experience

Birmingham (Office Based)

Up to £55,000 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 as a responsible person 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.

• Analyzing 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, with significant experience as a responsible person.

• 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.

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