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Date Added: Tue 03/11/2020

GDP Responsible Person

Glasgow, UK
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Job Type: Permanent

Salary: £55000 - £65000 / annually

Job Title: Responsible Person

Location: Glasgow

Salary: £45-55k

My client, a Pharmaceutical distribution company are looking for an experienced Responsible Person to join their team. To be sucessful you will need to have experience as an RP working on a licence and a strong understanding of GDP.

Main Duties and Responsibilities

  • The responsible person should fulfil their responsibilities personally and should be continuously contactable.
  • The responsible person may delegate duties but not responsibilities.
  • The responsible person has the authority to take decisions with regard to their responsibilities.
  • The responsible person must ensure that the company can demonstrate GDP compliance at all times and that public service obligations are met.
  • The responsibilities of the responsible person include but is not limited to:

Quality Management

The individual shall ensure that a quality management system proportionate to the distributor's activities is implemented and maintained including:

  • Quality risk management
  • Corrective and preventative actions (CAPA) to address deviations
  • Change control
  • Measurement of performance indicators and management review

Personnel

The responsible person is required to:

  • Understand their own responsibilities
  • Carry out all duties in such a way as to ensure that the wholesale distributor can demonstrate GDP compliance
  • Define personal and staff roles, responsibilities and accountabilities and record all delegated duties
  • Ensure that initial and continuous training programmes are implemented and maintained
  • Ensure all personnel are trained in GDP, their own duties, product identification, the risks of falsified medicines and specific training for products requiring more stringent handling
  • Maintain training records for self and others and ensure training is periodically assessed

Premises & Equipment

  • Ensure that appropriate standards of GDP are maintained for own premises and contracted storage premises
  • Identify medicinal products, legal categories, storage conditions and different Marketing Authorisation types
  • Maintain the safety and security of medicinal products within the appropriate environments, including product integrity and product storage
  • Use the appropriate systems to segregate, store and distribute medicinal products
  • Maintain records for the repair, maintenance, calibration and validation of equipment including computerised systems
  • Ensure storage areas are temperature mapped, qualified and validated

Documentation

The individual shall focus on:

  • The accuracy and quality of records
  • Contemporaneous records
  • Records storage
  • Maintaining comprehensive written procedures that are understood and followed
  • Ensure procedures are valid and version controlled

Operations

  • Carry out due diligence checks and ensure that suppliers and customers are qualified
  • Ensure all necessary checks are carried out and that medicinal products are authorised for sale
  • Manage authorised activities to ensure operations do not compromise the quality of medicines and can demonstrate compliance with GDP
  • Demonstrate the application of activities and provisions in accordance with the wholesale distribution authorisation and of company processes and procedures
  • Ensure that any additional requirements imposed on certain products by national law are adhered to e.g. specials, unlicens
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