Lead Responsible Person/ RP Pharmaceutical

Russell Taylor Group Ltd; Widnes; On-site; GBP 40,000 - 60,000; Full time

Job summary

A global pharmaceutical company is seeking a Responsible Person for its distribution operations in Widnes. This permanent role requires expertise in Good Distribution Practices and quality management systems. The selected candidate will ensure compliance with storage and handling guidelines, manage audits, and address customer quality complaints. Ideal candidates will hold an up-to-date Responsible Person qualification and have experience in a GMP/GDP environment.

Qualifications

• Hold an up-to-date Responsible Person qualification.
• Worked in a similar GMP/GDP setting with knowledge of CAPA.
• Experience with quality management and GDP compliance.

Responsibilities

• Ensure overall quality requirements for pharmaceutical products.
• Demonstrate knowledge of GDP legislation and practices.
• Manage audits and maintain compliance documentation.

Skills

Knowledge of Good Distribution Practice (GDP)

Quality Management Systems (QMS)

Experience in GMP/GDP settings

Understanding of CAPA

Familiarity with auditing requirements

Education

Up-to-date RP qualification

Job description

Overview

Our client, a global pharmaceutical company whose brands are widely recognized, is recruiting a Responsible Person (RP) for its pharmaceutical distribution operations. The role is based in Widnes, with coverage of other Liverpool sites, and is a permanent appointment.

Location & Type

Location: Widnes (covering other Liverpool sites).
Type: Permanent.

Responsibilities

• Overall quality requirements for different dosage forms (product presentations), reasons why certain storage conditions are required, and risks associated with any temperature excursions during storage and/or transportation.
• Demonstrate up-to-date knowledge of Good Distribution Practice (GDP) requirements and how they are embedded within the systems and processes at the wholesale distributor.
• Key areas of knowledge and experience include:
  • Storage conditions/requirements for different types of pharmaceutical products in the facility.
  • Basic understanding of degradation pathways and typical stability profiles of pharmaceutical products.
  • GDP legislation and relevant guidance, including national requirements.
  • Requirements for storage facilities, temperature control and monitoring programmes, including mapping and qualification.
  • Quality Management Systems (QMS) and effective management.
  • Current data integrity expectations.
  • Handling of returns/complaints/recalls.
  • Bona Fide checks.
  • Risks associated with falsified medicines.
  • Robust Technical (Quality) Agreement expectations with contractors and outsourcing companies.
  • Narcotics and psychotropic substances, plus other controlled medicines legislation.
  • Auditing requirements and techniques.
• Experience with picking/packing procedures and FEFO (First Expiry, First Out) principles; managing quality complaints and customer queries including service issues; active involvement in GDP regulatory inspections; familiarity with GDP operations of the licence holder; internal audits to monitor QMS, identify weaknesses and improvement opportunities; customer audits of the site and external audits covering various stages in the distribution process; supplier and customer approval process; creating/maintaining/auditing documentation and records to ensure GDP compliance; understanding of typical IT systems used in GDP activities; security of storage and traceability during storage and onward distribution.

Qualifications

• Hold an up-to-date RP qualification.
• Have worked in a similar GMP/GDP setting with a good understanding of CAPA, OOs, OOt, change controls etc.

Important Information

We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or GDPR please get in touch with us.