Quality Assurance Manager - Responsible Person Experience

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 as a Responsible Person working in a Good Distribution Practice (GDP) environment with 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/responsible person 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.

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