Job Description
Profile: Mentor and Part-time Responsible Person (RPi)
Professional Summary: An experienced pharmaceutical professional with over 10 years of expertise in regulatory compliance, quality assurance, and mentoring within the international) pharmaceutical industry. Proven track record of mentoring teams and ensuring compliance with MHRA regulations and maintaining high standards of quality and safety in pharmaceutical importation and distribution.
Key Qualifications:
* Mentoring and Training: Skilled in mentoring and training staff, developing people in UK specific expectations and requirements for RPi.
* Responsible Person (RPi) Certification: Certified and experienced in fulfilling the role of Responsible Person as per MHRA guidelines.
* Regulatory Compliance: In-depth knowledge of UK pharmaceutical regulations, including Good Distribution Practice (GDP) and Wholesale Dealer’s Authorization (WDA) requirements
* Quality Assurance: Extensive experience in quality management systems, risk management, and continuous improvement processes.
Specific requirement:
* Professional Certifications: Responsible Person (RPi) Certification for an international company that has outsourced manufacturing, logistics and distribution outsourced outside of the UK
Skills:
* Strong leadership and communication skills
* Training and mentoring mindset
* Proactive and solution-focused
* Regulatory Compliance
* Quality Assurance
* Risk Management
* Continuous Improvement
Personal Attributes:
* Open communication style
* Internal drive to improve others
* Detail-oriented and highly organized
* Committed to maintaining high standards of quality and compliance
Availability: 1 or 2 days a week on site for a period of 6-12 months
Objective:
* Working with Affiliate QA lead to get lead added as RPi to the WDA
* Working with current RPi on Astellas WDA to extend experience
* Acting as RPi in case current RPi on Astellas WDA is not available