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Head of Quality/ QP
2 months ago
We are currently looking for a Head of Quality to join a leading pharmaceutical company based in the St Hertfordshire area. As the Head of Quality you will be responsible for providing quality direction and oversight for the formulation and process development activities of the company's products. Ensuring that all products are manufactured in compliance with the requirements of the relevant Product Licenses and fully adhere to the Good Manufacturing Practice (GMP) guidelines as specified in the EU directives. If the Head of Quality is a Qualified Person (QP), the mandatory responsibilities associated with the QP role also apply.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Head of Quality will be varied however the key duties and responsibilities are as follows:
1. Lead and refine the quality management system, ensuring continuous improvement, compliance with GMP, and successful management of inspections and audits.
2. Ensure compliance with manufacturing standards, manage QC processes, approve/reject materials, and maintain rigorous validation systems and staff training.
3. Address and escalate key quality issues, oversee complaint resolution, implement KPIs, and conduct regular management reviews to ensure ongoing quality improvement.
4. Stay informed on regulatory changes, manage technical documentation, and work with cross-functional teams to ensure product compliance and support new product development.
ROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as the Head of Quality we are looking to identify the following on your profile and past history:
1. Relevant degree in a pharmaceutical/scientific related field.
2. Proven industry experience in a pharmaceutical manufacturing company, with minimum of 5 years experience leading teams/departments.
3. A working knowledge and understanding of drug development process and the Global Regulatory Requirements and regulations related to GxP
