Responsible Person
Do you have a passion for quality and ensuring the safe supply of medicines?
We are seeking a highly motivated and experienced Responsible Person (RP) to join a new team in Luton. This is an excellent opportunity for an individual with a strong understanding of Good Distribution Practice (GDP) to play a key role in ensuring the quality and compliance of site operations.
About the Role:
In this role, you will be responsible for overseeing all aspects of our Quality Management System and ensuring that they comply with all relevant regulations, including the Human Medicines Regulations 2012 and the MHRA guidelines.
Your key responsibilities will include:
- Implementing and maintaining a robust Quality Management System
- Managing authorised activities and ensuring the accuracy and quality of records
- Overseeing GDP training programmes and ensuring staff competence
- Coordinating and managing product recalls
- Handling customer complaints effectively
- Approving suppliers, customers and subcontracted activities
- Performing regular self-inspections and implementing corrective actions
- Deciding on the fate of returned, rejected, or falsified medicinal products
- Ensuring compliance with the terms of our licence and relevant legislation
- Monitoring storage conditions and adherence to GDP guidance
- Receiving reports from the Deputy RP (when duties are delegated)
- Maintaining vigilance against falsified medicines entering the supply chain
- Keeping records of delegated duties
- Approving returns to saleable stock
- Ensuring compliance with additional regulatory requirements
Who We Are Looking For:
- A qualified RP with experience in the pharmaceutical industry
- Strong, up-to-date knowledge of Good Distribution Practice (GDP)
- Excellent communication and interpersonal skills
- The ability to work independently and as part of a team
- A proactive and problem-solving approach
- The ability to work effectively in a fast-paced environment
- Meticulous attention to detail and record keeping skills
- A strong understanding of relevant legislation and regulations
- Working knowledge of the MHRA and EMA roles and responsibilities
Benefits:
- Competitive salary and benefits package
- Opportunity to work in a dynamic and growing company
- Location: Luton, UK
- Hours: Monday-Friday, 9:00am - 6:00pm
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
Reference: 52653275
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