Job Title: Responsible Person
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:
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
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
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
- 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