Qualified Person
- Added on:
- 31 Oct 2019
- Contract type:
- Permanent
- Reference:
- 12476
- Location:
- Home Counties
- Base Salary:
- 80000
Description
Based in the Home Counties and Reporting to the Pharmaceutical Director, this is an Opportunity for a QP to Establish Themselves as a Key Member of the Leadership Team of this Major Supplier of Pharmaceutical Products
Primarily Responsibility for the Certification of Products with Other Associated Responsibilities
ROLE
- Able to Display and Communicate an In-Depth Knowledge of cGMP Regulatory Standards, Licensing the Unlicensed Products and Sterile Production
- Review and Approval of Standard Operating Procedures
- Review and Approval of Study Protocols and Auditing (Internal and External)
- Auditing for GMP, GCP, GDP and GLP Purposes
- Experience of Quality Management Systems, Covering All Aspects of Licensed Manufacturing Sites
- Active Participation in Troubleshooting of GMP, GCP and GLP Issues
- Input into the Regulatory Strategy for the Development of Pharmaceutical Products in the UK
- Licensing the Unlicensed Medicines for the UK Market
- Liaising with the Regulatory Authority/MHRA Contact for All Pharma Products Sold in UK
- Working Cross Functionally with Pharmacovigilance, Regulatory Affairs and Clinical Research
- Involvement in All Aspects of Sterile Production, Including Design, Installation and Operational
- Plan, Execute and Supervise Standard Training Programmes for All New Employees and Maintain Continuous Training for All Staff
- Develop Training Courses as a Separate Business Unit Within the Department
- Maintain All Professional Knowledge Databases
- Other Projects and Other Assignments
REQUIRED EXPERIENCE (Essential)
- Eligible to be Named as a Qualified Person
- Licensed Manufacture of a Range of Dosage Forms, (Solid Oral, Liquid Oral, Sterile, Semi-Solid and Topical)
- Parallel Import Operations
- Practical Auditing for GMP, GCP, GDP and GLP Purposes
- Quality Management Systems
REMUNERATION
- Basic Salary of £80K Per Annum
RESPOND
- Call Terry Blaney on +44 (0)1580 211221 to Learn More about this Career Opportunity or e-Mail terry@arxconsultancy.com with Your Application, Including Your Current CV