Job Description
Responsible Person (RP), Pharmaceutical
Location: Widnes (covering other Liverpool sites too)
Type: Permanent
Our client. a global pharmaceutical company whose brands are easily recognized is looking to recruit for an RP/ Responsible Person
The Role:
Overall quality requirements for different dosage forms (product presentations), reasons why certain storage conditions are required, and risks associated with any temperature excursions occurring during storage and/or transportation.
The RP must be able to demonstrate up to date knowledge of GDP requirements, and how these are embedded within the systems and processes implemented at the wholesale distributor.
Some key areas of knowledge and experience are listed: Knowledge - Storage conditions/requirements for different types of pharmaceutical products in their facility.
Basic understanding of degradation pathways and typical stability profiles of pharmaceutical products; - GDP legislation and relevant guidance; (including any national requirements) - Requirements for storage facilities, temperature control and monitoring programmes, including mapping and qualification; - Quality Management Systems (QMS) and how to manage these effectively; - Understanding of current data integrity expectations - Handling of returns/complaints/recalls; - Bona Fide checks; - Risk...