Job Description:
We are seeking a Head of Quality for our Clients manufacturing facility in the Midlands. In this role, you will oversee the Quality Assurance and Quality Control Teams, supporting the implementation, maintenance, and continual improvement of the company QMS and undertaking the role of QP named on the relevant MIA(s).
Key Responsibilities:
* Ensure an appropriate compliant QMS is in place on site to ensure best possible outputs in terms of site compliance (including Regulator Inspections) and throughput of product.
* Perform QP certification of product for release to market, as necessary to meet business requirements and in accordance with the Purchasing release schedule.
* Site quality operations and batch certification: Manage and co-ordinate activities of the Quality team ensuring all arrangements are in place for the allocation of activities to ensure compliance and timely batch release.
* Foster and promote GMP, GDP and the associated Quality Management Systems within the site. Challenge ways of working to seek improved compliance and performance where necessary, ensuring that the Quality System is implemented and maintained in relation to the manufacture and batch certification.
* Support and undertake investigations relating to quality non-conformances, complaints, recalls and product batch investigations.
* Review and approval of QMS documentation relating to Quality activities.
* Establish and Monitor appropriate KPIs for all Quality activities. Ensure effective site Change Review Board in operation and coordinate generation and maintenance of Technical Agreements for all quality related activities.
* Coordinate the management of complaints, manage through to closure any Recalls relating to activities.
* Educate and train employees on Quality Management Systems and procedures.
* Maintain current awareness of applicable legislation, guidelines and current industry practices.
Requirements:
* Eligible to be named on a manufactures licence as Qualified Person under EU Council Directive /83/EC as amended.
* Quality Management experience in the pharmaceutical industry 5 years minimum.
* QC experience desirable
* Regulatory experience desirable.
What We Offer:
* A highly competitive salary and benefits package.
* The opportunity to work with a portfolio of products diversified across multiple therapeutic areas, with particular strengths in analgesics and anti-infectives.