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SalaryOur client is an established pharmaceutical company looking to add a Quality Director to head up a Quality department. The Quality Director will promote and integrate quality into every aspect of the business ensuring GMP compliance and meeting the authority's expectation.
The role holder will perform all duties required of a Quality Director, provide leadership to the Quality Teams, improve the QMS, provide expertise and guidance on changing regulatory landscape and input in operations that protects company reputation whilst maintaining product supply to market. The role holder will be named as Qualified Person on Manufacturer and Importer Authorisations.
The Role:
- Work with and manage the Quality team to enable the efficient evaluation and release of medicinal products
- Work closely and effectively with other departments such as Regulatory Affairs, Compliance, Validation, Sales, Logistics etc to the highest quality and compliance standards and maintaining product supply to market
- Act as Qualified Person to the business
- Host regulatory inspections for the business and provide support to sister company for regulatory inspections and conduct self-inspection program
- Oversee the Pharmaceutical Management System. Implement the current GMP regulations and industry best practices, where applicable
- Support and develop the QA team
- Support/lead manufacturing deviation or testing out-of-specification/out-of-trend investigations
- Audit the contract manufacturing organisation and laboratory against EU GMP and relevant regulations and guideline
Qualifications and Skills:
- Qualified Person (QP)
- Knowledge and experience in manufacturing and testing of oral dosage forms and topical products
- Experience in releasing medicinal products in a fast-paced environment
- Experience in managing a QA team
- Communication skills with internal and external customers
- Overseas audits
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales
