Responsible Person

1 week ago

Newcastle under Lyme, Staffordshire, United Kingdom SKC Recruitment Full time

Job Description

Key Responsibilities & Requirements

Internal & External Stakeholder Management:

Maintain key relationships with internal staff, including the License Holder and RP Deputy, to ensure seamless collaboration and effective communication.

Liaise with external stakeholders such as MHRA inspectors, customers, and suppliers/partners to foster strong partnerships and ensure compliance with regulatory requirements.

Quality Management & GDP Compliance:

Oversee all GDP and quality-related activities for the UK business, ensuring adherence to Wholesale Distribution Authorization (WDA), EU GDP Guidelines 2013/C 343/01, and MHRA guidelines.

Implement and maintain the Quality Management System (QMS) and approve all GDP SOPs/documentation to ensure compliance and efficiency.

Conduct regular self-inspections, audits, and mock recalls to identify areas for improvement and ensure quality standards are met.

Handle all UK quality complaints and collaborate with the Global Complaint Management Team to resolve issues promptly and effectively.

Decide on the disposition of returned, recalled, or suspected falsified products, ensuring compliance with regulatory requirements and company policies.

Oversee RPi release on all deliveries of POM and P products, ensuring timely and accurate processing.

Ensure compliance for medical devices and cosmetic registration with UK authorities, maintaining up-to-date knowledge of regulatory requirements.

Training & Compliance:

Ensure all UK staff are trained in GDP and relevant SOPs, maintaining training records and conducting ongoing training sessions to ensure competency and compliance.

Provide training to staff and ensure they are competent in handling pharmaceutical products, adhering to company policies and regulatory requirements.

Regulatory Compliance & Documentation:

Ensure that licenses, supplier approvals, and customer bona fides are maintained, approving all subcontracted GDP activities to ensure compliance.

Manage documentation for product quality, traceability, complaints, returns, recalls, deviations, and CAPA, maintaining accurate and up-to-date records.

Be the primary contact for MHRA and legally responsible for compliance, ensuring that all regulatory requirements are met.

Operational Oversight & Continuous Improvement:

Handle supplier and customer approval activities, maintaining GDP records for at least 10 years to ensure compliance and accountability.

Identify areas for process improvement to enhance quality and compliance, regularly updating the UK Senior Management Team with quality reports and updates.

Decision Making & Risk Management:

Approve any decisions relating to quarantine, recall, or disposal of products, ensuring that decisions do not compromise compliance or product safety.

Manage non-conformance issues and implement corrective/preventative actions (CAPA), ensuring that quality standards are met and compliance is maintained.

Ensure decisions related to product safety and quality do not compromise compliance, maintaining a high level of personal accountability and proficiency in IT systems.

Skills & Qualifications:

Proven experience as a Responsible Person with 3 to 5 years in a similar role, with up-to-date knowledge of GDP legislation and the UK regulatory framework.

Strong communication skills with the ability to engage different audiences, with the ability to work independently, analyze data, assess risks, and propose solutions.

Degree in Life Sciences or Biological Science, with desirable skills including experience as a Responsible Person for Import (RPi) and previous ownership of a QMS and experience within a pharmaceutical manufacturer.

Personal Attributes:

Achievement-oriented, self-motivated, and solutions-focused, with excellent planning, time management, and problem-solving skills.

High level of personal accountability and proficiency in IT systems, with a strong commitment to quality and compliance.

Working Environment:

Office-based in the Midlands, with potential travel within the UK and internationally, flexible working arrangements with 3 days in the office and 2 days from home, and a UK driving license required.

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