Quality Assurance Manager

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:

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

  
  


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

  
  


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

  
  


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

  
  


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

  
  


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

  
  


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

  
  


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

  
  


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

  
  


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

  
  


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

  
  

Requirements:

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  Proven experience in a quality assurance role, with significant experience as a responsible person.

  
  


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  Strong background in Good Distribution Practice (GDP) environments.

  
  


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  Excellent knowledge of ISO 9001 and ideally ISO 13485 standards.

  
  


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  Exceptional analytical and problem-solving skills.

  
  


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

  
  


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

  
  


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  Experience in supplier and vendor management.

  
  

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