Quality Manager

Quality Assurance Manager/Responsible Person

Birmingham (Office Based)

Up to £85,000 DOE

Urgently needed

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.
• Ensure compliance with Good Distribution Practice (GDP) regulations, safeguarding product quality during storage and distribution.
• Verify that all imported medicinal products comply with the necessary regulatory and quality standards before distribution.
• Liaise with suppliers and regulatory authorities to resolve any issues related to product importation and quality assurance.
• 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
• Existing RP and eligible to be an RP
• 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.