Quality Assurance Manager
2 weeks ago
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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