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Responsible Person (RPi)

A leading Pharmaceutical company based in the London/Surrey border is seeking Part-time Responsible Person (RPi) to join their team. As the Responsible Person (RPi) you will be responsible for ensuring the compliant and efficient implementation and maintenance of the Affiliate Quality Management System, whilst mentoring a junior RPi.


KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Responsible Person (RPi) will be varied; however, the key duties and responsibilities are as follows:

1. As the Responsible Person (RPi) you will support the QA Lead in overseeing activities governed by Good Distribution Practice Guidelines (GDP Guidelines), ensuring they are performed and recorded as defined in the Quality Management System, and implement improvements to correct inefficiencies and non-conformances.

2. As the Responsible Person (RPi) you will cooperate with the QA Lead on communications with competent authorities responsible for pharmaceutical affairs, especially on changes and recalls.

3. As the Responsible Person (RPi) you will perform local batch acceptances as RPi with support from the QA Lead and mentor a junior RPi.

4. As the Responsible Person (RPi) you will mentor the QA Lead in UK-specific activities and requirements to allow them to qualify as RPi and support the QA Lead in case of inspections and audits.


ROLE REQUIREMENTS:

To be successful in your application to this exciting role as the Mentor and Part-time Responsible Person (RPi), we are looking to identify the following on your profile and past history:

1. Relevant degree in a scientific or pharmaceutical discipline.

2. Proven industry experience in regulatory compliance and quality assurance within the pharmaceutical sector. You must be a licensed RPi with the MHRA. 

3. A working knowledge and practical experience with UK pharmaceutical regulations, including Good Distribution Practice (GDP) and Wholesale Dealer’s Authorization (WDA) requirements.

Key Words: Mentor / Responsible Person / Quality Assurance / Good Distribution Practice / Pharmaceutical Compliance / Regulatory Affairs / Batch Acceptance / Quality Management System / MHRA / Pharmaceutical Industry / RP / RPi / Import / Importing

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
 

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.

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