Mantell Associates is partnered with a well-established Pharmaceutical company with a strong product portfolio, who is seeking an experienced Consultant Responsible Person (RP) to ensure lawful release of medicinal products and compliance with UK / EU regulatory requirements.
This consultant role provides expert RP services on a contract basis, ensuring high standards of quality and regulatory assurance.
Consultant RP - Responsibilities:
* Serve as the Responsible Person (RP) for product batch release, ensuring all released medicinal products meet UK / EU GMP, MHRA and other applicable regulatory standards
* Review and approve batch records, manufacturing and control data, deviations, change controls, and QC / QA documentation prior to release
* Ensure compliance with Good Manufacturing Practice (GMP) regulations and the UK Medicines & Healthcare products Regulatory Agency’s expectations for RP functions
* Lead investigations and root cause analysis for out-of-specification (OOS) / out-of-trend (OOT) results; approve corrective and preventive actions (CAPA) if applicable
* Support audits and inspections related to manufacturing, batch release, RP responsibilities; ensure readiness and provide responses to regulatory queries
* Liaise closely with Quality Assurance, Regulatory Affairs, QC, Manufacturing to maintain alignment of quality systems, documentation, and release processes
Consultant RP - Requirements:
* Proven experience acting as a Responsible Person in a pharmaceutical manufacturing or distribution environment (finished products) in the UK / EU
* Deep knowledge of GMP regulations, UK (MHRA) and EU requirements, batch release standards, deviation management, CAPA, change control processes
* Strong track record in document review, batch release, investigation of OOS / deviations, and decision authority as RP or equivalent senior QA role
* Excellent attention to detail, decision-making capability, and ability to balance regulatory risk with business needs
* Strong communication skills, able to interface with internal cross-functional teams and regulatory authorities as needed
* Based in the UK, eligible to work on contract basis, with availability for on-site tasks including batch release and inspections
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.