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