Quality Assurance Manager
3 weeks ago
Job Title: Quality Assurance Manager
About the Role:
- The Quality Assurance Manager will be responsible for developing, implementing, and maintaining robust quality assurance policies and procedures.
- The role involves planning and conducting regular internal audits to ensure compliance with company standards and regulatory requirements.
- The Quality Assurance Manager will also be responsible for ensuring compliance with Good Distribution Practice (GDP) regulations, safeguarding product quality during storage and distribution.
- Additionally, the role requires verifying that all imported medicinal products comply with the necessary regulatory and quality standards before distribution.
- The Quality Assurance Manager will liaise with suppliers and regulatory authorities to resolve any issues related to product importation and quality assurance.
- Oversight of product testing and inspection processes is also a key responsibility to guarantee product quality and consistency.
- Maintaining meticulous documentation and records of QA activities, including test results, inspection reports, and audits, is essential.
- The role involves analyzing 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 is also a key aspect of the role.
- Evaluating and managing suppliers and vendors to ensure they meet quality standards is a critical responsibility.
- The Quality Assurance Manager must ensure compliance with ISO 9001 and ISO 13485 standards and other relevant regulatory requirements.
- Investigating and resolving quality-related issues and complaints, implementing corrective and preventive actions (CAPA), is an essential part of the role.
- Collaboration with other departments, such as production, engineering, and R&D, is required to integrate quality throughout the product lifecycle.
- The role involves 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
- Experience in supplier and vendor management
Salary: Up to £85,000 per annum
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