- Responsible Person/ Quality Assurance Officer
- 3rd Party Logistics Pharmaceutical Wholesaler
Alex Dobson is recruiting for a Responsible Person/ Quality Assurance Officer with an internationally renowned transport and logistics company. This role is an exciting opportunity for someone to move there career forward within the pharmaceutical logistics sector.
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).
The Requirements and Experience
To be eligible as Responsible Person named on the Wholesale Dealer's Authorisation
To be able to assist and where necessary take charge of:
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
Extensive knowledge of GDP and GMP
Practical experience in Supply Chain, Production and Quality Assurance
Experience of hosting MHRA inspections, client audits and self-inspections
To assist in development of the core quality systems including but not limited to;
- Manage the change control system, monitoring and tracking of all change requests.
- Maintain the deviation, complaint and CAPA logs and follow up on the completion of corrective and preventative actions where required.
- Manage the annual self-inspection program, perform internal audits and follow up including monitoring and tracking completion of subsequent actions.
- Update metrics / KPIs to facilitate management review of the system.
- Provide internal training and mentoring in the QMS.
- Maintain a system for managing oversight of the supplier assurance systems and assist with supplier assurance activities (i.e. external audits, meetings).
- Ensure that the QA group responds to the requests of other teams in a timely and supportive manner.
- Liaise with managers of other functions to facilitate good communication and the elimination of barriers.
- Raise the profile of quality within the Company.
- Carry out duties in accordance with the WDA (H),MS and IMP(MIA), Company's policies and "Procedures
- Manual" and to report any quality / compliance concerns to the Quality and general management function
- Be proactive in identifying, gaining agreement and implementing improvements to the QMS
Quality Assurance Officer, Responsible Person, WDA, GMP, GDP, ISO, QMS, Pharmaceutical, Logistics, QA, Shipping, Freight Forwarding, QMS, MS, IMP. CAPA, MHRA, Supply Chain, Production, Hounslow, Heathrow, Middlesex.
This is a permanent position.