Responsible Person (RP), GDP Pharmaceutical
Location: - Bolton/ Wigan area (SITE BASED) Salary: - £50,000 - £60,000 Depending on experience
Our Client, a leading Pharmaceutical / distribution outfit are expanding and looking to bring in a new GDP - RP for their modern site in Wigan.
The successful applicant will be responsible for ensuring GDP is adhered to throughout business operations. The company is currently going through a period of development and needs someone with a track record of managing change to ensure the QMS is tailored to the business, staff have appropriate training and the company complies with all GDP and Home Office requirements.
- All duties as set out in the EU Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01) and the Human Medicines Regulations 2012.
- Carrying out management reviews and self-inspections independently.
- Implementing and maintaining a suitable QMS.
- Promoting, encouraging, and driving continuous improvement throughout the business.
- Effectively training staff at all levels on GDP criteria and requirements.
- Applying for variations on the PCL portal when required.
- Auditing third parties as necessary.
- A life science, pharmacy, or other relevant scientific degree
- Worked as an RP within the past two years (with an MHRA person number).
- Experience or participation of MHRA inspections.
- Experience of working with senior stakeholders.
- Have a proven track record of maintaining a QMS.
- Understanding of the FMD, including verification and decommissioning.
- Experience of working within a manufacturing environment (desirable).
- Hold an enhanced DBS check issued by Security Watchdog (desirable).
- Have passed an accredited "Gold Standard" course within the past 2 years (desirable).
- Understand requirements surrounding the export of pharmaceutical products (desirable, training can be provided for the right candidate).