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Compliance Manager Health Hub

Want to raise standards on a global scale? As a Compliance Manager Health Hub, you’ll have the freedom to shape the way we develop and deliver our products worldwide.

 

Compliance Manager Health Hub, Fixed Term Contract

Slough, Berkshire 

Competitive Salary & excellent benefits package

 

The primary responsibility of the Health Hub GDP Compliance Manager is to ensure compliance of all Health products and processes within the supply/distribution chain in the Health Hub. You will also provide support for the Responsible Persons and Responsible Persons for Import for all activities and responsibilities relating to GDP for the Health Hub. 
    
The scope of this role is to work as an RP under the Medicinal Products wholesaled using the Health Hub WDA.

 

 

Key responsibilities:

 

Local QMS

  • Responsible for supporting the Responsible Person in ensuring the GDP Compliance of the Health Hub Quality Management System and ensuring compliance to the regulatory requirements, Marketing Authorisation and Wholesaler Distribution Authorisation.
  • Responsible for supporting the management team to enable the development and implementation of the local Quality Management System (QMS) to ensure fully compliant products and systems.
  • Provide leadership on continuous improvement projects, quality initiatives, etc. as established by corporate Quality Management.
  • Work with local functions to develop and maintain all relevant procedures in line with the requirements of the Global QMS & associated policies, relevant codes of practice and GDP.
  • Change Management - Ensure a robust and effective change control system is in place to ensure business changes are effectively managed.
  • Training – Ensure an effective training system is in place for the business.
  • Issue Management - Investigate quality issues (Non-conformances) and failures (CEP Events) and apply
  • Corrective and Preventive Actions (CAPA) to prevent recurrence. Ensure that improvements to products and procedures can be identified and fixed.
  • Audit/Inspection Management – Ensure that processes are in place to assess the adequacy and effectiveness of the local QMS. Audit should cover all aspects of the global and local QMS to ensure
  • compliance. 
  • Transporters – Partner with procurement to ensure that hauliers selected are compliant with GDP and all relevant TAs and audits are in place prior to commencement of activities.
  • Perform activities delegated by the RP/RPi to support the batch review and release process.
  • Responsible for compliance management of the Home Office Controlled Drugs.

 

You should also understand…

  • The role of the local competent authority in the licensing of medicines.
  • The current European regulations related to Human Medicines Regulations in relation to wholesale distribution (EU GDP 2013/C 343/01).
  • The current European Pharmaceutical Directive related to Wholesale Distribution of Medicinal Products
  • The requirements of the Misuse of Drugs Act 1971, the Misuse of Drugs Regulations 2001.

Global / Local Quality:

  • Work with global and local teams to ensure implementation of appropriate controls to ensure consistent quality of products.

 

Inspections:

  • Responsible for supporting external inspections by External Authorities, third parties and RB Corporate group.
  • Responsible for supporting follow ups and responses after external inspections.
  • Responsible for leading Home Office inspections.

 

Knowledge and experience required:

  • At least 5 years’ experience working in a quality compliance function in Healthcare, Pharmaceutical, or Medical Device related industry.
  • Experience in developing and maintaining a robust QMS in a Healthcare, Pharmaceutical, or Medical Device related industry.
  • Clear understanding and ability to assess and act upon product safety, quality, efficacy, and compliance risks.
  • Good understanding of regulatory, GMP and GDP requirements relevant to a regulated product e.g., EU GMP, EU GDP, WHO, PIC/S, CFR 21 Part 210/211.
  • Clear understanding to ensure operations do not compromise the quality of products and can demonstrate compliance with GDP.
  • Influencing skills in areas with no direct reporting authority.
  • Strong interpersonal and communication skills.
  • Auditing skills, appropriate qualifications in auditing an advantage.
  • Language skills appropriate to the assigned country and/or regional cluster.

You’ll love it because… 

…you’ll get to make an impact like never before. The products you help us get out there will make people’s lives better. Our iconic brands will provide an incredible platform for you. And our dynamic, ownership-driven culture will help bring the very best out of you, every day.

Equality

All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law. 


Job Segment: Medical, Medical Device, Healthcare

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