SKC Recruitment Ltd
Responsible Person RP
Job Location
East Midlands, United Kingdom
Job Description
Responsible Person RP
Key Responsibilities & Requirements
Internal & External Stakeholder Management:
Maintain key relationships with internal staff, including the License Holder and RP Deputy.
Liaise with external stakeholders such as MHRA inspectors, customers, and suppliers/partners.
Quality Management & GDP Compliance:
Manage all GDP and quality-related activities for the UK business.
Ensure compliance with 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.
Conduct regular self-inspections, audits, and mock recalls.
Handle all UK quality complaints and collaborate with Global Complaint Management Team.
Decide on the disposition of returned, recalled, or suspected falsified products.
Oversee RPi release on all deliveries of POM and P products.
Ensure compliance for medical devices and cosmetic registration with UK authorities.
Training & Compliance:
Ensure all UK staff are trained in GDP and relevant SOPs.
Maintain training records and conduct ongoing training sessions.
Provide training to staff and ensure competency in handling pharmaceutical products.
Regulatory Compliance & Documentation:
Ensure that licenses, supplier approvals, and customer bona fides are maintained.
Approve all subcontracted GDP activities.
Manage documentation for product quality, traceability, complaints, returns, recalls, deviations, and CAPA.
Be the primary contact for MHRA and legally responsible for compliance.
Operational Oversight & Continuous Improvement:
Handle supplier and customer approval activities.
Maintain GDP records for at least 10 years.
Identify areas for process improvement to enhance quality and compliance.
Regularly update 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.
Manage non-conformance issues and implement corrective/preventative actions (CAPA).
Ensure decisions related to product safety and quality do not compromise compliance.
Skills & Qualifications:
Proven experience as a Responsible Person with 3 to 5 years in a similar role.
Up-to-date knowledge of GDP legislation and UK regulatory framework.
Strong communication skills with the ability to engage different audiences.
Ability to work independently, analyze data, assess risks, and propose solutions.
Degree in Life Sciences or Biological Science.
Desirable Skills:
Experience as a Responsible Person for Import (RPi).
Previous ownership of a QMS and experience within a pharmaceutical manufacturer.
Personal Attributes:
Achievement-oriented, self-motivated, and solutions-focused.
Excellent planning, time management, and problem-solving skills.
High level of personal accountability and proficiency in IT systems.
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. UK driving license required
Location: East Midlands, GB
Posted Date: 10/3/2024
Key Responsibilities & Requirements
Internal & External Stakeholder Management:
Maintain key relationships with internal staff, including the License Holder and RP Deputy.
Liaise with external stakeholders such as MHRA inspectors, customers, and suppliers/partners.
Quality Management & GDP Compliance:
Manage all GDP and quality-related activities for the UK business.
Ensure compliance with 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.
Conduct regular self-inspections, audits, and mock recalls.
Handle all UK quality complaints and collaborate with Global Complaint Management Team.
Decide on the disposition of returned, recalled, or suspected falsified products.
Oversee RPi release on all deliveries of POM and P products.
Ensure compliance for medical devices and cosmetic registration with UK authorities.
Training & Compliance:
Ensure all UK staff are trained in GDP and relevant SOPs.
Maintain training records and conduct ongoing training sessions.
Provide training to staff and ensure competency in handling pharmaceutical products.
Regulatory Compliance & Documentation:
Ensure that licenses, supplier approvals, and customer bona fides are maintained.
Approve all subcontracted GDP activities.
Manage documentation for product quality, traceability, complaints, returns, recalls, deviations, and CAPA.
Be the primary contact for MHRA and legally responsible for compliance.
Operational Oversight & Continuous Improvement:
Handle supplier and customer approval activities.
Maintain GDP records for at least 10 years.
Identify areas for process improvement to enhance quality and compliance.
Regularly update 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.
Manage non-conformance issues and implement corrective/preventative actions (CAPA).
Ensure decisions related to product safety and quality do not compromise compliance.
Skills & Qualifications:
Proven experience as a Responsible Person with 3 to 5 years in a similar role.
Up-to-date knowledge of GDP legislation and UK regulatory framework.
Strong communication skills with the ability to engage different audiences.
Ability to work independently, analyze data, assess risks, and propose solutions.
Degree in Life Sciences or Biological Science.
Desirable Skills:
Experience as a Responsible Person for Import (RPi).
Previous ownership of a QMS and experience within a pharmaceutical manufacturer.
Personal Attributes:
Achievement-oriented, self-motivated, and solutions-focused.
Excellent planning, time management, and problem-solving skills.
High level of personal accountability and proficiency in IT systems.
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. UK driving license required
Location: East Midlands, GB
Posted Date: 10/3/2024
Contact Information
| Contact | Human Resources SKC Recruitment Ltd |
|---|