Quality Assurance Manager

3 days ago


Birmingham UK, West Midlands, United Kingdom 1Tech Staffing Limited Full time

Quality Assurance Manager/Responsible Person

Birmingham (Office Based)

Up to £85,000 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/Responsible Person 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.
  • 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.



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