The company specialize in Pharmaceutical material warehousing, inventory management and distribution. They focus on warehousing and logistics services that are fully automated and allow the monitoring of inventory 24 hours a day. Pharmaceutical companies rely on them for distribution and controlled supply chain management programs. This is specifically tailored for bulk temperature controlled supplies all over the world which adhere to transit service and storage regulations such as Good Distribution Practices (GDP), Good Manufacturing Practices (GMP) and Wholesale Distribution Authorization (WDA). Close to Heathrow Airport, the company offers state of the art services to the Pharmaceutical industry.
The Requirements and Experience
You will be named as a Responsible Person on the Wholesale Dealer's Authorisation and will have the following responsibilities:
- Ensuring that a compliant quality system is maintained
- Ensuring GDP and GMP compliance and best practice within all regulated activities
- Assisting in conducting internal audits of the quality system
- Ensuring that adequate records are maintained and a suitable documentation control system is in place
- To identify risks and to take necessary preventative measures pro-actively hosting and reporting of Regulatory inspections, Client Audits and supplier audits Liaise with regulatory authorities (MHRA, Home Office) on Licence applications, drug returns and product recalls.
- Pro-active and solutions driven, with the ability to work to strict deadlines with a high level of accuracy
- Hosting MHRA inspections, client audits and self-inspections
- To assist in development of the core quality systems including managing the change control system, monitoring and tracking of all change requests, maintaining the deviation, complaint and CAPA logs and following up on the completion of corrective and preventative actions.
- Manage the annual self-inspection program, perform internal audits and follow up including monitoring and tracking completion of subsequent actions.
- Raising the profile of Quality within the company.
- Be proactive in identifying, gaining agreement and implementing improvements to the QMS
The company are looking for an RP who has just gained their license and is looking to work alongside a QP in order to progress within the industry. You will need to have knowledge of GDP and GMP and practical experience in Supply Chain, Production and Quality Assurance. You will need to have hosted MHRA inspections and client audits before, preferably within a 3rd party logistics provider, though candidates will be considered from the other side of the fence as well. You must be an excellent communicator with strong people skills and a positive, pragmatic approach to Quality.
This is a permanent position.