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Home > Life Sciences > GDP Responsible Person

Job Reference: HH/HQ1304

GDP Responsible Person

  • Glasgow, Glasgow City, Scotland
  • Permanent / Full Time
  • Life Sciences Team
  • £45000 - £55000

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, unlicensed imports & controlled drugs

Complaints, returns, suspected falsified medicinal products and medicinal product recalls

  • Ensure relevant customer complaints are dealt with effectively, informing the manufacturer and/or marketing authorisation holder of any product quality/product defect issues
  • Decide on the final disposition of returned, rejected, recalled or falsified products
  • Approve any returns to saleable stock
  • Coordinate and promptly perform any recall operations for medicinal products
  • Co-operate with marketing authorisation holders and national competent authorities in the event of recalls
  • Have an awareness of the issues surrounding falsified medicines

Outsourced Activities

  • Approve any subcontracted activities which may impact on GDP

Self-Inspection

  • Ensure that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place

Transportation

  • Apply the appropriate transport requirements and methods for cold chain, ambient and hazardous product
  • Ensure all transport equipment is appropriately qualified

Brokers

  • Ensure that transactions are only made with brokers who are registered
  • Ensure that any broker activities performed are registered

If this is of interest, please click on apply now to forward your CV for review. If you’d like more details, please contact Harvey in the Life Sciences team.

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