An Exciting opportunity has arisen for an experienced Responsible Person (RP) to take a senior position in the regulatory team at growing Pharmaceutical Distributor in London!
If you're passionate about maintaining the highest standards in Pharmaceutical Distribution, read on to find out more...
Responsible Person (RP)
London, NW10 0AB
- Full time, permanent
- £35,000 - £55,000 per annum depending on experience
Please Note: Applicants must be authorised to work in the UK
Our client is a leading pharmaceutical distributor with multiple GDP distribution facilities and a GMP assembly unit. They are committed to maintaining the highest standards of Good Manufacturing and Distribution Practice (GDP) and regulatory compliance. Their dedication to quality, safety, and customer satisfaction sets them apart in the industry.
The Role:
They are seeking a highly skilled and experienced Senior Responsible Person (RP) to lead their regulatory team.
The Senior RP will ensure compliance within the company is maintained as well as ensuring that the conditions under which the Wholesale Dealer's Authorisation (WDA) was granted are complied with and that the quality of medicinal products handled is maintained according to the requirements of their marketing authorisations.
Key Responsibilities:
- Regulatory Compliance: Fulfil the responsibilities of a RP as defined under the Wholesale Dealer's Authorisation (WDA). Act as the primary contact with the Medicines and Healthcare products Regulatory Agency (MHRA)
- Quality Management System (QMS): Ensure a robust QMS is implemented and maintained across all company operations
- Record Management: Oversee the management of authorised activities and ensure the accuracy and quality of records
- Documentation: Support the creation, revision, and approval of written procedures and other regulatory compliance documents
- Training: Ensure that initial and continuous training programs are implemented and maintained
- Supplier and Customer Approval: Ensure that all suppliers and customers are approved
- Controlled Drugs: Ensure legal requirements for handling controlled drugs (narcotics) are complied with
- Quality Management Reviews: Chair periodic Quality Management Review Meetings and lead process improvement initiatives
- Subcontracting: Approve any subcontracted activities impacting GDP
- Internal Audits: Ensure self-inspections (internal audits) are performed at appropriate regular intervals, following a prearranged program, and that necessary corrective measures are put in place
- Recall Operations: Coordinate and promptly perform any recall operations for medicinal products
- Complaint Management: Ensure effective handling of customer complaints
- Product Disposition: Decide on the final disposition of returned, rejected, recalled, or falsified products
- Compliance with National Laws: Ensure adherence to additional national requirements for specific products as per Article 83 of Directive 2001/83/EC
The Ideal Candidate:
You will have a keen eye for detail and a strong commitment to regulatory compliance as well as:
- A degree in Pharmacy, Life Sciences, or a related field with a minimum of 3 years in a similar role within the pharmaceutical industry
- An understanding of MHRA Good Distribution Practices (GDP) and relevant certifications in quality management, regulatory affairs, or related fields
- Strong leadership, communication, and organisational skills, with proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) at an intermediate level.
Benefits:
Employees are valued and offered a comprehensive benefits package to support their well-being and professional growth, including a competitive salary, professional development opportunities, a friendly and inclusive work environment, and comprehensive health benefits.
Don't miss out, apply now!
How to apply for the role:
If you have the skills and experience required for this position, click "apply" today and check your inbox for an email providing more information on how to tailor your application and provide a cover letter or any supporting documents.
You must be authorised to work in the UK. No agencies please.
Flat Fee Recruiter is an advertising agency promoting this role on behalf of the employer. You will be contacted directly by the employer and not Flat Fee Recruiter should they wish to move forward with your application.
Other suitable skills and experience include Responsible Person (RP), Quality Affairs Specialist, Compliance Manager, Pharmaceutical Quality Control Manager, GMP Auditor, Distribution Manager, Pharmaceutical Consultant, Quality Systems Coordinator.