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