Regulatory Assurance Officer

Overall Objective
We are rcruiting on behalf of a client for Regulatory Assurance Officer

• Job Title Regulatory Assurance Officer
  
• Salary £29,000 to £32,000
  
• Location Walsall
  
• Working Hours Monday to Thursday 8am - 5pm Friday 8am-12pm
  
• Holidays 20 days plus 8 Bank Holidays
  
• Sector is Pharmaceuticals, we are open to candidates who have experience working in highly regulated industries
  You will work effectively with other departments within the business as necessary, to ensure compliance with all relevant company and regulatory standards and maintain the safety, quality and efficacy of all products procured, handled, repackaged and supplied by the company.
  Duties and Responsibilities:
  
• Preparation of Raw Product Specification: -
  New set up.
  Changing in import packaging (Outer pack, inner pack imported leaflet, any additional devices/components included in import packaging).
  Licence taken off No Process.
  Licence taken of Suspended.
  Variation granted.
  
• Preparation of Material Specification: -
  New set up.
  Licence taken off No Process.
  Licence taken of Suspended.
  Variation granted (e.g., PIL).
  
• Preparation of Master Packaging Record: -
  New set up.
  Licence taken off No Process.
  Licence taken of Suspended.
  Variation granted (e.g., PIL).
  
• Ensuring artwork template approval is carried out prior to external printing components.
  
• Ensuring superseded version of components are sent for destruction.
  
• Documentation Control and Archiving: -
  Ensuring superseded versions of documents are removed for use.
  Ensuring documentation for licence(s) on No Process or Suspended are removed for use.
  Ensuring Component Specifications and master BPRs for licences due to PIL update are removed for use.
  Ensuring master BPR electronically removed for use due to update.
  Ensuring updated labels are moved to live folder for production use and old labels are removed for use.
  Ensuring correct version of PIL available for production and old versions are removed for use.
  
• Creating repack link requested by production.
  
• Maintaining QF spreadsheet, Master Batch Packaging spreadsheet.
  
• Informing production of any inconsistencies.
  
• Raising quality incident if needed.
  
• Partially conducting Bollino / Vignette authenticity checks as part of RPS preparation.
  
• Informing regulatory about product ID failures and booking off samples from stock as required.
  
• Notifying the relevant departments to send surplus samples for destruction.
  Other duties:
  
• Ad-hoc duties as they arise and when needed.
  
• Additional hours are worked as required to suit business needs.
  
• Reporting any issues and any concerns regarding Health and Safety to Line Manager.
  
• Compliance with GDP/GMP.
  
• Attend all mandatory trainings (e.g. Health and Safety)