Job Ref: 215731544

Date: 2022-02-03 17:06:18

Apply Now

Regional Responsible Person – South

Regional role covering Maidstone, Bridgwater, Suffolk Park and Rugby

You will be responsible for the implementation of the wider compliance agenda at regional level and will provide consultancy and direction at a senior level across all business areas. You will be experienced in the field of regulatory compliance and management systems, as well as the development of the Quality and Regulatory Management System in line with the contractual obligations with the Department of Health.

You will have input to key business processes such as management systems review, GDP, Quality Risk Management and Food hygiene, driving process improvements and metrics across those areas. This role is focused towards supporting the integrated management systems, Food, De natured alcohol, Medical Devices and Pharmaceutical activities and ensuring that the regional business area understands and meets its compliance obligations including Unipart Logistics, internal, customer and or regulatory requirements.

You will lead responsibility for maintaining the regional sites Wholesale Dealer Authorisations (WDA). You would have an access to the executive leadership of the business as expected by the MHRA requirements.

Responsibilities:

Maintain a high level of quality system and local regulatory knowledge and awareness of proposed changes
Act as a Responsible Person overseeing the application of GDP and MDR legislative requirements
Carry out due diligence checks and ensure that suppliers and customers are qualified
Ensure that any additional requirements imposed on certain products by national law are adhered to e.g. specials, unlicensed imports & controlled drugs.
Have oversight and provide assurance to the Head of Regulatory Compliance that the appropriate transport requirements and methods for cold chain, ambient and hazardous product are in place and maintained.
Perform activities to support the risk management processes to ensure effective management, timely reporting, review and escalation of quality/compliance risks identified within warehouse and distribution activities.
Ensure all new and existing outsourced providers are assessed for impact on product quality/compliance, undertake compliance assessments on any outsourced storage facilities prior to any activity.
Effectively oversee corrective and preventative action plans linked to warehousing and distribution.
Oversee root cause analysis investigations into deviations and support the Operational Excellence Manager’s (OEM’s) to develop CAPA’s. Track and review CAPA actions on a routine basis.
Complaints, returns, suspected falsified medicinal products and medicinal product recalls

Requirements:

3 – 5 years’ experience in a quality/compliance role
Knowledge of the products traded under the wholesale dealer authorisation
Practical experience in the handling, storage and distribution of medicinal products.
Strong understanding of and experience working in quality assurance systems particularly in the areas of medicinal products, medical devices & food.
At least 1 year’s managerial experience in wholesale distribution of products of the same sort of scale and scope as the license for which they are nominated as RP.
Good knowledge of regulatory requirements pertaining to medicines, medical devices & food
Good knowledge of effective quality documentation systems
Qualified auditor
Understands the role of the MHRA in the licensing of medicines
Worked previously in the role of GDP Responsible Person (RP) or RP Deputy
Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook

About Unipart Group:

You may remember Unipart as the company who in the 1970s revolutionised the automotive parts industry. Unipart is a different company today with clients such as Vodafone, Sky, Jaguar Land Rover and, the NHS. The Unipart Group is an independent manufacturing, logistics and consultancy company who employs nearly 10,000 employees worldwide and has an annual turnover of more than £1 billion.

Location: Milton Keynes
Job Type: Full Time, Permanent
Hours: 40 hours per week
Salary: Up to £55,000 per annum

You may have experience of the following: Quality Assurance, Quality Assurance Engineer, QA Manager, Risk, Assurance, ISO, Quality Control Manager, Logistics Manager, Supply Chain, 3PL, Project Manager, Third Party Logistics, Healthcare, Pharmaceutical, Logistics, etc.

Ref: (Apply online only)

Apply Now